
Editor’s Note: This September, the 28th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO 2025) was successfully held in Jinan under the theme “Standardized Care, Innovation-Driven Progress.” Following the meeting, Oncology Frontier – Urology Frontier invited Professor Xinan Sheng of Peking University Cancer Hospital to discuss the “Chinese path” embodied in the CSCO Renal Cell Carcinoma (RCC) Guidelines, recent progress with innovative agents, and the future direction of precision therapy.
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Oncology Frontier – Urology Frontier: As a standing member and secretary-general of the CSCO RCC Expert Committee, you have helped draft and update multiple guideline editions. Could you share your experience growing with CSCO? How have successive updates to the CSCO RCC Guidelines better reflected the uniqueness and clinical needs of Chinese patients?
Professor Xinan Sheng: The CSCO RCC Guidelines occupy an important position in kidney cancer care. Since the first edition in 2013, nearly 10 versions have been released. The guidelines keep pace with international advances and incorporate the latest evidence, while remaining firmly rooted in China’s clinical practice and real-world context.China faces several thorny issues in RCC management, including limited drug accessibility and a lack of data specific to Chinese patients.
In recent years, under successive chairs of the CSCO RCC Committee, we have actively advanced standardized care and launched or joined numerous clinical studies many of them testing first-in-class or China-innovated drugs. Through sustained efforts, we have accumulated a substantial body of clinical evidence. As a result, the CSCO RCC Guidelines are grounded in our national context rather than being a simple copy of the NCCN or ESMO guidelines, and they are crafted to meet China’s practical clinical needs.
In advanced RCC, a number of high-quality China-led studies have emerged for example, RENOTORCH and ETER100, both randomized phase III trials conducted domestically that provide level-one evidence for the guidelines, based on real data from Chinese population.
In terms of treatment strategy, the CSCO RCC Guidelines emphasize risk-stratified care—classifying patients as favorable, intermediate, or poor risk. Take favorable-risk patients: although some studies have shown that targeted therapy plus immunotherapy can be effective in select scenarios, the actual advantage over targeted monotherapy has not been consistently superior.
We therefore continue to recommend targeted monotherapy in this group. While long-term follow-up suggests dual-immunotherapy (IO/IO) can also benefit favorable-risk patients, drug accessibility for dual-IO remains limited in China, and many clinicians have relatively less hands-on experience managing dual-IO toxicities. Accordingly, our guidelines do not recommend dual-IO for favorable-risk patients.This approach reflects China’s realities—balancing access with homegrown evidence—to deliver RCC recommendations that truly fit our clinical environment.
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Oncology Frontier – Urology Frontier: In recent years, multiple China-led studies—including ETER100—have been presented at international congresses such as ASCO and ESMO. How has this international visibility elevated the standing of Chinese genitourinary oncology and enhanced the global influence of the CSCO guidelines?
Professor Xinan Sheng: Chinese physicians in GU oncology have been exploring actively for years. Back in 2019 at ASCO, I participated in a poster discussion the first time a Chinese clinician in our field took the stage in that capacity sharing data on a China-innovated drug, disitamab vedotin (RC48), for HER2-positive urothelial carcinoma. Subsequently, we conducted the CONCEPT study comparing vorolanib plus everolimus with everolimus alone; the results were presented at ASCO as a poster and, at that time, set a record for median survival in the second/third-line setting.
Over time, more results have reached major stages. For example, a bladder cancer study from the Second Hospital of Tianjin Medical University was selected for ASCO oral presentation. The China-led advanced RCC trials RENOTORCH and ETER100, with participation from many domestic centers, were presented at ESMO 2023. This year at ASCO-GU, several domestic studies were selected for oral presentations: the Renji Hospital team (Shanghai Jiao Tong University School of Medicine) shared a first-line TKI/IO regimen for FH-deficient RCC (FH-RCC); I presented the RC48-C017 study on neoadjuvant TKI/IO in muscle-invasive bladder cancer (MIBC); and another early-phase study also drew wide attention.
These developments illustrate a shift in the role of Chinese GU oncologists on the international stage from attendees, to active participants, to presenters of major research. This change reflects the rising quality of our clinical research and growing recognition and citation by international peers. Take RENOTORCH, reported at ESMO 2023: focusing on TKI/IO in poor-risk advanced RCC, it currently provides the only level-one evidence tailored to this specific subgroup. Based on this study, the 2024 ESMO RCC Guidelines included toripalimab plus axitinib as a recommended regimen an encouraging endorsement of domestic research and a point of pride for us.Thanks to the relentless efforts of our colleagues nationwide, China’s GU oncology research continues to make breakthroughs and expand its international influence. We are finding our voice globally and even shaping clinical thinking among overseas physicians evidence that we are steadily advancing toward the international forefront, supported by solid strength and vast potential.
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Oncology Frontier – Urology Frontier: Compared with other cancers, biomarker development in RCC (e.g., PD-L1, TMB) appears more challenging. Where do you see breakthroughs coming from? In precision medicine for RCC, what research and collaborations can CSCO help catalyze?
Professor Xinan Sheng: Targeted therapy in advanced RCC started relatively early—anti-angiogenic agents entered clinical practice two decades ago, and TKI/IO combinations followed. Yet in precision oncology, advanced RCC still has clear gaps and lacks major breakthroughs.Biomarkers such as PD-L1 and TMB, while widely studied in immuno-oncology, have not become decisive tools for treatment selection in RCC. In the past one to two years, studies of kidney injury molecule-1 (KIM1) have gained traction. Current data suggest KIM1 may influence treatment decisions to some extent. Overall, however, biomarkers have not yet assumed a dominant role in precision therapy for advanced RCC—largely due to the biology of RCC itself—so we still lag behind other tumor types.I’m confident that as research on KIM1 and other candidates deepens, biomarker development in RCC will accelerate. We hope that within the next 3–5 years we can identify clinically actionable biomarkers that guide therapy. Many domestic teams are already devoting themselves to this effort.With the expansion of treatment options in advanced RCC, the demand for reliable biomarkers is becoming increasingly urgent. We very much look forward to clinically applicable advances—ideally reflecting China’s own research contributions—that can be translated directly into practice.