Editor’s note: The 2024 European Society for Medical Oncology (ESMO) Annual Meeting took place from September 13 to 17 in Barcelona, Spain. At the event, Dr. Liangyou Gu from the Urology Department of Chinese PLA General Hospital shared findings from the Phase II NEOTAX study on neoadjuvant therapy for renal cancer patients with venous tumor thrombus. The study demonstrated that preoperative treatment with toripalimab combined with axitinib successfully downgraded the level of inferior vena cava (IVC) tumor thrombus in some patients, significantly improving perioperative outcomes. Urology Frontier had the privilege of interviewing Dr. Liangyou Gu at the event for an in-depth analysis of the NEOTAX study, treatment strategies for renal cancer with venous tumor thrombus, and future research directions.

01 Urology Frontier: In locally advanced renal cancer, what are the specific risks associated with venous system invasion?

Dr. Liangyou Gu: Venous system invasion in locally advanced renal cancer presents a significant clinical challenge. It not only complicates surgical procedures but also dramatically increases the risk of intraoperative complications due to extensive involvement, ranging from the renal vein to the inferior vena cava, and even the right atrium. This complexity demands exceptional technical skill and surgical experience, with particular attention to preserving major vessels and critical organs.

02 Urology Frontier: In your clinical experience, how do you formulate treatment strategies for renal cancer patients with venous tumor thrombus to reduce complications and improve prognosis?

Dr. Liangyou Gu: For renal cancer patients with venous tumor thrombus, our team has developed a systematic approach based on years of research and practice. We tailor specific techniques and optimize surgical strategies according to the tumor thrombus classification, significantly reducing surgical difficulty and complication rates. In particular, for patients with high-grade thrombi, we focus on lowering thrombus height and classification through preoperative neoadjuvant therapies, simplifying the surgical process and improving perioperative safety, thereby enhancing overall prognosis.

03 Urology Frontier: You presented the NEOTAX study at the ESMO meeting. Can you share the effectiveness and safety of neoadjuvant therapy for renal cancer with venous tumor thrombus?

Dr. Liangyou Gu: The NEOTAX study is a single-arm, interventional Phase II trial and an important step in our exploration of neoadjuvant therapy. It evaluates the efficacy of toripalimab combined with axitinib as a neoadjuvant therapy for clear cell renal cell carcinoma (ccRCC) patients with inferior vena cava tumor thrombus (Mayo classification II-IV). The primary endpoint was the downgrading rate of IVC tumor thrombi, with secondary endpoints including surgical method adjustments, percentage change in thrombus length, response rate (RECIST v1.1), progression-free survival (PFS), surgical complications, and biomarker exploration.

Among 25 patients treated, 11 had their tumor thrombi downgraded, with no cases of Mayo classification progression. Notably, even those who did not achieve downgrading exhibited significant reductions in tumor thrombus height. Twenty-one patients successfully underwent surgery, with 13 patients benefitting from surgical adjustments due to reduced thrombus height. These adjustments simplified the surgical approach and significantly reduced perioperative complications, providing tangible benefits for the patients. During follow-up, we observed a 1-year progression-free survival rate of 89.1%, showcasing the potential of neoadjuvant therapy in improving short-term outcomes. However, some 2-year PFS results did not meet expectations, likely due to initial high disease stages and cases of lymph node and distant metastases. Nonetheless, these findings demonstrate that preoperative neoadjuvant therapy holds great promise as a strategy for reducing thrombus height and optimizing surgical conditions in patients with thrombi classified at grade II or higher.

04 Urology Frontier: Looking ahead, what future research does your team plan to conduct to further improve survival outcomes for renal cancer patients with venous tumor thrombus?

Dr. Liangyou Gu: Looking ahead, our team will continue to explore the prediction of neoadjuvant therapy efficacy. Based on existing clinical cohort data, we are working to develop more precise prediction models to identify the patients most likely to benefit from neoadjuvant therapy. We will also continue to monitor advancements in immunotherapy and immune cell typing, aiming to offer more personalized treatment recommendations for patients. Additionally, we will explore new ways to improve survival rates, such as optimizing drug selection strategies for different patient groups and focusing on the importance of postoperative adjuvant therapy and holistic management. These efforts will collectively help to advance treatment for renal cancer with venous tumor thrombus.

Dr. Liangyou Gu

Dr. Liangyou Gu is an associate professor, associate chief physician, and master’s supervisor at the Urology Department of Chinese PLA General Hospital. He serves as the secretary of the Clinical Research Office of the Urology Branch of the Chinese Medical Association and is a member of the Beijing Urological Society’s Basic and Translational Medicine Group. He was selected for the 2023 Beijing Science and Technology Star Program. Professor Gu has led two National Natural Science Foundation projects, participated as a key researcher in National Key Research and Development Projects, and published 33 papers in top journals such as Innovation, European Urology, Cancer Treatment Reviews, and The Journal of Urology. His research has been featured at international conferences, including ESMO, EAU, SIU, and UAA. Professor Gu has been recognized with the first prize of the Chinese Medical Science and Technology Award and multiple awards from Chinese PLA General Hospital.