In order to climb a new peak in the diagnosis and treatment of urological tumors, promote the improvement of the level of clinical research on urological tumors, and help the technological breakthroughs and drug innovation in the field of urological tumors in mainland China, the "China Urological Oncology Clinical Research Summit Forum" sponsored by the China Medical Education Association and co-organized by the Department of Urology and Medical Oncology of Peking University Cancer Hospital, the Department of Urology of Peking University First Hospital and the Department of Urology of the PLA General Hospital came into being.
On April 21, 2024, the 2nd China Urological Oncology Clinical Research Summit Forum was held in Beijing, which is full of spring. The conference set up five major links (keynote report, kidney cancer, urothelial carcinoma, distinguishing right from wrong in clinical research, prostate cancer), urology, medical oncology, radiotherapy, nuclear medicine and other multidisciplinary alliances, injecting innovative solutions, novel ideas and unique perspectives into the clinical research of urological tumors, creating a wonderful academic feast for the participating scholars!
At the beginning of the conference, Professor Sheng Xinan from Peking University Cancer Hospital, Professor Zhang Cuijian from Peking University First Hospital, and Professor Gu Liangyou from the General Hospital of the People's Liberation Army of Chinese jointly opened the academic event, and invited the experts of the presidium of the conference, Academician Zhang Xu of the PLA General Hospital, Professor Guo Jun of Peking University Cancer Hospital, Professor He Zhisong of Peking University First Hospital, Professor Wei Qiang of West China Hospital of Sichuan University, and Professor Li Changling of Cancer Hospital of Chinese Academy of Medical Sciences to address the conference.
Statement by the President of the Conference
Academician Zhang Xu first extended a warm welcome to the experts who participated in the meeting, and emphasized in his speech that the incidence of urological tumors is rising, especially prostate cancer, and there are still many unsolved problems in clinical practice, which has brought great pressure to the work and life of patients. The goal of this urological oncology clinical research summit forum is to promote multidisciplinary in-depth cooperation, jointly discuss the direction of clinical research, jointly build a platform for the transformation of scientific research results, and jointly promote the research and development of new technologies and drugs, so as to improve the diagnosis and treatment level of urological tumors in mainland China. It is expected that the participating experts and scholars can learn from each other, cooperate closely and innovate together, and bring revolutionary progress and breakthroughs to the diagnosis and treatment of urological tumors with an international perspective and cutting-edge thinking.
Professor Guo Jun hit the nail on the head and clearly expounded the core purpose and motivation of this seminar. He pointed out that there are many talents in the field of urological oncology, but on the international stage, the mainland's contribution to the field of urological oncology research is minimal, and compared with other cancer research fields in China, the clinical research of urological oncology is overshadowed. The purpose of this conference is to gather wisdom, gather resources, establish consensus, closely unite multiple disciplines such as urology, medical oncology, and radiotherapy, jointly promote innovation and development, and carry out high-level clinical research in a down-to-earth manner, so as to contribute Chinese wisdom to the international urologic oncology field and the domestic market and industry, and push the clinical research of urological oncology in China to a new height.
Professor Li Changling pointed out that compared with previous academic conferences, the Urologic Oncology Clinical Research Summit Forum has always emphasized the innovation of research, aiming to promote the innovation and development of clinical research on urological oncology. He expressed his approval of Professor Guo Jun's encouragement and encouragement to young doctors in the field. He also emphasized that the guests participating in this forum are all industry leaders, and it is believed that through fierce discussions and debates, more innovative sparks of ideas will be stimulated and new academic consensus will be born. It is expected that this forum can make a high-level start, advance steadily, and reach new academic heights.
Professor Ho said that in 2005, when experts in the field of urological oncology first joined the Chinese Society of Clinical Oncology (CSCO), there were few representatives, and the focus was mainly on surgery rather than clinical research, but promoting the innovation and development of clinical research is crucial to improve the benefits of patients. It is hoped that through the in-depth discussion and exchange of participants in this forum, a solid foundation will be laid for future cooperation, and at the same time, innovative thinking will be stimulated to promote new breakthroughs in clinical research on urological tumors. He emphasized that under the careful guidance and encouragement of experts represented by Professor Guo Jun, he expects young doctors to make unremitting efforts and achieve more outstanding results.
Professor Wei Qiang mentioned that the opening of the first forum is still vivid, and the forum has brought together many outstanding talents in professional fields, and he believes that the forum will achieve better results year by year. Urologic oncology research has gradually developed from an underappreciated area to a hot field of concern. However, despite the growing interest, the level of clinical research has not yet reached the expected level. It is expected that through the in-depth exchanges of the forum, more exploratory research can be transformed into clinical research, so as to promote the clinical research of urological oncology to a new height. In particular, he pointed out that he looks forward to bringing more hope to patients through everyone's joint efforts.
01
Keynote Speech
The keynote speech session of the conference was co-chaired by Professor Yao Xin from Tianjin Medical University Cancer Hospital, Professor Xu Wanhai from Harbin Medical University Cancer Hospital (online), Professor Zhou Aiping from the Cancer Hospital of the Chinese Academy of Medical Sciences (online), and Professor Ma Xin from the General Hospital of the Chinese People's Liberation Army.
Professor Guo Jun interpreted the "2023 China Urologic Oncology Clinical Research Report". The overview of clinical research on urological oncology in China, the inventory of approved indications for urological oncology in China in 2023, the analysis of hot areas of international urological oncology clinical research, and the clinical research on urological oncology in China in 2023 were introduced. He pointed out that the clinical research of urological oncology in China needs to be paid attention to, and he looks forward to attracting more people's attention to the field of urological oncology and striving for more resources with the joint efforts of everyone in the future. Although there are a considerable number of clinical studies on urological tumors in China, most of them are bioequivalence studies, there are few innovative studies, phase III clinical studies are still insufficient, and new target studies are very weak.
Academician Zhang Xu gave a wonderful report on the topic of "Research Progress in Telesurgery". He said that the minimally invasive technology system of surgery is basically mature, and only by knowing the future can we win the future, and proposed that the two important development directions of surgery are intelligent surgery and telesurgery. The work of the team in remote surgical animal experiments was introduced, focusing on the bidirectional, single-arm and exploratory clinical trials between Beijing and Sanya, in which the solution strategies of data stream transmission delay and the impact of different network bandwidths on remote surgery were analyzed. He emphasized that China's vast territory, the development of intelligent and remote robotics technology, and the cross-regional sharing of high-quality medical resources. The development of telesurgical technology will greatly improve the accessibility and efficiency of medical services, and provide better and more convenient medical services for the majority of patients.
Subsequently, under the chairmanship of Professor Fan Yu from Peking University First Hospital, Professor Chen Peng from the Affiliated Cancer Hospital of Xinjiang Medical University, Professor Wang Haitao from the Second Hospital of Tianjin Medical University, Professor Zhang Sheng from the Affiliated Cancer Hospital of Fudan University, and representatives of the clinical trial sponsors had a heated discussion on the topic of "High-quality Development of Clinical Research on Urologic Oncology" on the reports of the two speakers, focusing on the future development direction of clinical research on urological oncology and how to complete high-quality clinical research.
Kidney cancer
The chapter on kidney cancer was co-chaired by Professor Shi Benkang from Qilu Hospital of Shandong University, Professor Zhang Yushi from Peking Union Medical College Hospital, Professor Liu Ziling from the First Hospital of Jilin University, Professor Zhang Jin from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Professor He Yi from the First Hospital of Jiaxing City, Zhejiang Province, and Professor Zhou Fangjian from the Cancer Prevention and Treatment Center of Sun Yat-sen University (online).
Researcher Ci Weimin of the Beijing Institute of Genomics, Chinese Academy of Sciences, shared his views on "Precision Medicine and Translational Research in Kidney Cancer". She said that the focus of precision treatment of tumors lies in precise typing and precision treatment, and deciphering the epigenome is an important way to achieve precision treatment. Renal cancer is a hot tumor sensitive to immunotherapy, and the combination treatment options are diverse, but not accurate, and the key scientific problem to be solved is to elucidate the epigenetic mechanism of transcriptional plasticity of kidney cancer tumor cells. In the future, we look forward to promoting randomized controlled clinical trials related to vitamin C and its derivatives, accurate classification of cancer thrombus, and the development of urinary tumor liquid biopsy technology.
Professor Zeng Hao from West China Hospital of Sichuan University made a leading speech and summarized the unmet clinical needs and explorations of kidney cancer. This paper briefly introduces the current status of perioperative treatment of renal cell carcinoma (RCC), the progression and exploration of advanced clear cell renal cancer, and the problems existing in the dilemma and challenges of non-clear cell renal cancer.
Professor Liu Zhenhua from West China Hospital of Sichuan University gave a detailed introduction to the dilemma and challenges of non-clear cell renal cancer (nccRCC). He pointed out that the clinical research of nccRCC has developed from targeted monotherapy, targeted combination, immune monotherapy, and double-immunization combination to target-immune combination, but the current effect is still not ideal. The overall quality of clinical trials in nccRCC is low, the sample size is small, and there are many confounding factors, and different subtypes of RCC are complex, involving different driver mutations, co-mutations, microenvironment and other factors. The development of high-quality nccRCC studies depends on multi-center cooperation based on the large number of domestic subjects, and it is necessary to explore umbrella studies of different driver types and the application of more novel anti-tumor mechanism drugs.
Professor Yan Xieqiao from Peking University Cancer Hospital shared his thoughts on the progression and exploration of advanced clear cell renal cancer. In his report, he concluded: (1) anti-angiogenesis targeting + immunotherapy is still the cornerstone of first-line therapy, and the advancement of new targeted drugs and potent tyrosine kinase inhibitors (TKIs) may be able to change the landscape of first-line therapy, more diverse and more potent immune checkpoint inhibitors (ICIs) are expected to enhance the efficacy of first-line therapy, and nuclide drugs are currently being explored. (2) There is still no standard treatment regimen for post-line therapy, and new TKIs after immunotherapy progression still need to be confirmed by data accumulation and prospective studies, more types of ICIs may need to be screened individually, and various new drugs continue to be guided by predictive indicators.
Professor Kong Wen from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine gave a detailed introduction to the current situation and thinking of perioperative treatment for the participating experts. He said that how to prevent recurrence and progression in the early kidney cancer population, how to improve the cure conversion rate in the locally advanced kidney cancer population, and how to prolong the survival time of the tumor in the metastatic kidney cancer population are the keys to improving the overall prognosis of kidney cancer. It is emphasized that "precision" is the key to solving the problem of adjuvant treatment of kidney cancer, and it is necessary to accurately select patients, accurately select drugs, and accurately evaluate the efficacy. Judging from the current data, the impact of neoadjuvant therapy on surgery is controllable, and how to sequentially integrate neoadjuvant and adjuvant therapy also needs to be explored in the future.
Finally, under the chairmanship of Professor Zeng Hao from West China Hospital of Sichuan University, Professor Guo Gang from the General Hospital of the People's Liberation Army, Professor Zhang Zhiling from the Cancer Prevention and Treatment Center of Sun Yat-sen University (online), Professor Wang Zhiyu from the Fourth Hospital of Hebei Medical University, Professor Xie Yu, Director of the Department of Urology of Hunan Cancer Hospital, and representatives of the sponsors of clinical trials discussed the topic of "The Next Era of Target-Free Integration".
03
Urothelial carcinoma
The chapter on urothelial carcinoma was chaired by Professor He Zhisong from Peking University First Hospital, Professor Han Weiqing from Hunan Cancer Hospital, Professor Shi Yanxia from Sun Yat-sen University Cancer Prevention and Treatment Center, Professor Yao Xudong from Shanghai Tenth People's Hospital, and Professor Yu Zhixian from the First Affiliated Hospital of Wenzhou Medical University.
Professor Sheng Xinan from Peking University Cancer Hospital analyzed the short-term and long-term concerns of tumor ADC treatment. He said that in recent years, ADC has been booming, more drugs are in research and development, and the ADC pipeline targets are relatively concentrated, including urothelial carcinoma, HER2 is the most concerned target, but the clinical application strategy of ADC, ADC product upgrade and the research and development of more ideal ADC are still important tasks for clinicians and even the industry. Professor Sheng elaborated that the depth and duration of single-agent response are limited, not all tumors can benefit, ADC resistance and toxicity problems, and the efficacy and safety of treatment in special populations are all current clinical dilemmas, and future research directions include the combination and rational sequencing of ADCs, the innovative application of biomarkers and effective targets, and the optimization strategy of ADC toxicity reduction.
Professor Li Hongzhao of the General Hospital of the People's Liberation Army gave a leading speech. This paper summarizes the unmet clinical needs and explorations of urothelial carcinoma. This paper introduces the problems of non-muscle-invasive bladder cancer (NMIBC), perioperative muscle-invasive bladder cancer (MIBC), bladder-sparing treatment, and metastatic urothelial carcinoma (mUC).
Professor Hu Hailong from the Second Hospital of Tianjin Medical University gave a wonderful report on "Research Status and Challenges of NMIBC", introducing the diagnosis, risk grouping and prognosis, treatment strategies and health economics of bladder cancer treatment. Standardize the application of BCG and pay attention to its adverse reactions, and believe that the corresponding clinical research of NMIBC needs to be more standardized, and the research related to health economics of NMIBC is a blue ocean. It is expected that in the future, advances in medical technology and a more precise understanding of diseases will further improve the quality of life of patients.
Professor Liu Zhuowei from the Cancer Center of Sun Yat-sen University introduced the current status and challenges of MIBC research, and pointed out that in the current 2024 European Urological Association (EAU24) guidelines, neoadjuvant + radical cystectomy is still the standard treatment for MIBC, and immunotherapy combination therapy will benefit more patients. Subsequently, the report focused on three themes: the best mode of perioperative treatment, the accurate prediction of perioperative efficacy and the best mode of surgical treatment, and listed a number of research results at home and abroad to show relevant exploratory results. In summary, the problems of MIBC are the exploration of the best mode of perioperative treatment, how to accurately predict the perioperative efficacy, and the exploration of the best mode of surgical treatment.
Professor Fan Jinhai of the First Affiliated Hospital of Xi'an Jiaotong University shared the content of "Bladder Defense". He pointed out that compared with the international level, the proportion of bladder-preserving treatment in China is very low, and the current triple bladder-preserving treatment is recommended by multiple guidelines. Clinically, the needs of bladder-sparing comprehensive therapy mainly include the following four points: accurate judgment of clinical complete remission (CR), how to further improve the clinical complete response rate (CCR) and improve long-term bladder survival, accurate prediction of neoadjuvant therapy effect and selection of appropriate populations, and selection and optimization of bladder-preserving comprehensive treatment strategies. A number of studies have shown that the conversion of neoadjuvant therapy to bladder-sparing therapy is feasible, and prospective exploration of subsequent treatment selection based on the status after neoadjuvant chemotherapy is being carried out, and it is expected that the selection of dominant populations based on biomarkers can be realized in the future.
Professor Li Juan from Peking University Cancer Hospital summarized the clinical research exploration of metastatic urothelial carcinoma in her report. The EV-302 study has completely revolutionized the treatment of advanced urothelial cancer, and immunotherapy has become an important way to treat advanced urothelial cancer. At present, relevant clinical research is mainly carried out in the direction of ICI therapy, bispecific antibodies, cell therapy and neoantigen vaccines. In first-line maintenance therapy, the Checkmate-901 study is expected to provide a new standard for first-line treatment of mUC, ICIs combined with ADCs/TKIs/novel antibodies are expected to be the game-changers for the next standard of treatment, and HER2-ADCs, ICIs and new ADCs, triple or multiple therapies may be the future direction.
Finally, Professor Zhang Peng from West China Hospital of Sichuan University presided over the meeting, Professor Dong Haiying from Zhejiang Provincial People's Hospital, Professor Shen Yijun from Fudan University Cancer Hospital, Professor Liu Xiaodong from the First Affiliated Hospital of Kunming Medical University, Professor Wang Jingjing from the Second Xiangya Hospital of Central South University, Professor Qin Shangbin from Peking University First Hospital and representatives of clinical trial sponsors discussed the difficulties faced by NMIBC and clinical research, how to carry out bladder preservation, how to treat people after ADC failure and how to carry out research.
04
Distinguishing between right and wrong in clinical research
Professor Zhang Aili from the Fourth Hospital of Hebei Medical University, Professor Liu Jiyan from West China Hospital of Sichuan University, and Professor Zhang Cuijian from the First Hospital of Peking University were invited to co-host this session.
First of all, Professor Yan Xieqiao from Peking University Cancer Hospital introduced the CONCEPT study. The CONCEPT study is a randomized, controlled, double-blind phase III clinical study evaluating voronib in combination with everolimus versus single-agent veronib and single-agent everolimus for the second-line treatment of advanced kidney cancer, and is the first large-scale phase III clinical original study in the field of urological oncology in China. Voronib is also the first small molecule targeted independent innovation drug for kidney cancer with China's independent intellectual property rights. The CONCEPT study design was based on the low toxicity of voronib as a single agent, and the combination of voronib and everolimus was validated. Finally, the results demonstrated the efficacy of voronib in combination with everolimus in the second-line treatment of advanced renal cancer.
Subsequently, Professor Li Hongzhao from the PLA General Hospital analyzed and interpreted the CheckMate 274 study. He concluded that nivolumab has made continuous breakthroughs in the immunotherapy of urothelial carcinoma, and finally opened a new era of tumor immunotherapy. The CheckMate 274 study was the first large, randomized adjuvant study to include bladder cancer and upper urothelial carcinoma, the first large, randomized study to explore adjuvant therapy in patients with pathological residual pathology after neoadjuvant cisplatin chemotherapy, and the first large, randomized study to explore adjuvant therapy for patients who were "not suitable for cisplatin".
Finally, Professor Gu Liangyou of the PLA General Hospital interpreted the ARASENS study. He said that the available evidence shows that prostate cancer is significantly heterogeneous in the early stages of the disease, and it is necessary to consider how to provide appropriate treatment options for patients individually. At the same time, combined with the clinical benefit and tumor heterogeneity, patients with metastatic hormone-sensitive prostate cancer (mHSPC) should be started early on combination therapy. ARASENS data and Chinese darolutamide + ADT real-world data show that darolutamide can quickly bring PSA to compliance. The ARASENS study showed that darolutamide was beneficial in high-tumor, high-risk and high-risk and new-onset disease, and the benefit was more significant in GS≥8 and Chinese groups. Patients with mHSPC have high demands for quality of life, and the ARASENS regimen has an excellent safety profile.
Professor Zhang Ruiyun from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Professor Zhang Shun from Drum Tower Hospital Affiliated to Nanjing University School of Medicine discussed the above three studies, analyzed the problems existing in current clinical research, including uneven research quality, non-standard study design and execution, etc., and put forward suggestions to improve the quality of research, such as standardizing research design and strengthening investigator training.
05
Prostate cancer
This session was presided over by Professor Lu Jiaju from Shandong Provincial Hospital, Professor Wang Baojun from PLA General Hospital, Professor Ye Xiongjun from the Cancer Hospital of the Chinese Academy of Medical Sciences, and Professor Fang Weijia from the First Affiliated Hospital of Zhejiang University School of Medicine.
Professor Yang Zhi from Peking University Cancer Hospital explained in detail the clinical practice and prospect of the integration of radiopharmaceutical diagnosis and treatment in China. This paper introduces the advantages of the integration of prostate-specific membrane antigen (PSMA) diagnosis and treatment in prostate cancer, that is, "see what I know, know what I see", which is more conducive to clinicians to make clinical decisions. PSMA PET has certain advantages in the diagnosis of prostate cancer, lymph node metastasis of prostate cancer, and bone metastasis of prostate cancer. The R&D probes of PSMA PET, such as AI18F-PSMA-BCH, [68Ga]Ga-P137 and [18F]AIF-P16-093, were introduced.
Professor Zhu Yao from Fudan University Cancer Hospital made a leading speech, summarizing the unmet clinical needs and explorations of prostate cancer, saying that the current exploration of precision treatment for prostate cancer is insufficient, the core therapy for prostate cancer is still androgen receptor inhibitor (ARi), and the nuclear therapy is full of prospects, and the joint exploration of targeted therapy and other drugs is also underway, and further optimizing the research design is the key to promoting the development of the field.
Professor Zhu Yao gave an in-depth explanation of the research progress and future exploration of new types of prostate cancer. He noted that the unmet medical needs may be improved by next-generation imaging technologies, while the clinically meaningful benefits of detecting and treating small/early metastases remain to be explored, and looks forward to the future use of AI to interpret heterogeneity and turn the differences between molecular imaging and conventional imaging into opportunities to create new treatment options. At the same time, the use of imaging to predict and select treatment response is crucial to achieve better treatment with PSMA, and it is expected that in the future, the most appropriate treatment for individual patients, individual lesions, and individual time can be achieved through accurate imaging and molecular typing.
Professor Shen Pengfei from West China Hospital of Sichuan University introduced the current situation and challenges of metastatic hormone-sensitive prostate in detail from the many problems to be solved in the application of PARPi, Lutetium-177-PSMA-617, combination therapy and primary radiotherapy in the mHSPC stage, and explained the research and exploration of new combination therapy in the mHSPC stage and the application exploration of primary radiotherapy/surgery in the mHSPC stage.
Professor Wang Jun from the Cancer Prevention and Treatment Center of Sun Yat-sen University brought the clinical research of limited-term prostate cancer, which is related to clinical research on ablation treatment, radical surgery, perioperative treatment, The clinical studies related to radiotherapy have been summarized, and it is pointed out that ablation therapy has received attention in recent years as a third potential local treatment option in addition to radical surgery and radiotherapy, but there is still a lack of evidence-based medical evidence to support it, and it is still necessary to explore whether to undergo pelvic lymph node dissection (PLND) in people with relatively low risk of lymph node metastasis, and the significance of PLND for the prognosis of patients.
Professor Li Siming from Peking University Cancer Hospital explained the problems of castration resistance to prostate cancer treatment. He said that at present, the treatment of non-BRCA mutant populations, ARi resistant populations and small cell neuroendocrine carcinoma (SCNC) transformation populations is still insufficient, and the clinical promotion of radionuclide therapy is limited, and immunotherapy is difficult. He also said that the emergence of new ADCs, immunotherapy with different mechanisms and even T-cell therapy may be conducive to breaking through the current predicament.
Subsequently, under the chairmanship of Professor Yu Wei from Peking University First Hospital, Professor Niu Shaoxi from the PLA General Hospital, Professor Guan Youyan from the Cancer Hospital of the Chinese Academy of Medical Sciences, Professor Li Jun from the Academy of Sciences of Sichuan Medical College, Professor Kang Lei from the First Hospital of Peking University, Professor Liu Yueping from the Cancer Hospital of the Chinese Academy of Medical Sciences and representatives of the sponsors of the clinical trial conducted a roundtable discussion on the topic of "The New Era after Endocrine Therapy". Late treatment and other issues are expressed.
Summary of the meeting
Summary of the meeting
Finally, the chairman of the conference, Professor He Zhisong and Professor Guo Jun, made concluding speeches respectively.
Professor He Zhisong said that this forum was rich in academic content, and received positive response and strong support from experts, and the discussion atmosphere was very warm. He sincerely thanked all the experts and teachers for their presence and guidance, and he hoped that in the future work, the participants could continue to work together to promote greater progress in clinical research on urological tumors.
Professor Guo Jun said that this forum has been fruitful and has gained a lot. It is hoped that this conference will make full use of the opportunity to "build bridges" for young experts, so as to better integrate into the cutting-edge research field. It is also expected to build a "bridge" of communication between clinical investigators and sponsors. At the same time, it is hoped that experts and scholars can strengthen cooperation and support in the future to jointly promote new breakthroughs in urological tumor research and bring hope to more patients.
Work together and walk side by side, and look forward to meeting with all experts and colleagues at the next China Urological Oncology Clinical Research Summit Forum!
Review丨Peking University Cancer Hospital Sheng Xinan
Finishing丨China Medical Tribune, Gui Jingjing, Huang Linlin, Jiang Yutong