Clinical Trial

Phase II-III Clinical Trial of PD1 Antibody (Toripalimab), Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors

Active, Not Recruiting Phase 2/3
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Summary
A randomized controlled, multicenter, open, seamless phase II-III clinical trial is designed to target patients with resectable intrahepatic cholangiocarcinoma with high-risk recurrence factors which has extremely low postoperative recurrence-free survival. In this study, we aim to compare the prognosis in intrahepatic cholangiocarcinoma between Toripalimab combined with leventinib and GEMOX neoadjuvant treatment and the current clinical surgical treatment (traditional group).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-12-14; most recent amendment 2025-08-27.
Status change: Recruiting → Active, Not Recruiting 2025-08-15
Trial Details
NCT Number NCT04669496
Lead Sponsor Shanghai Zhongshan Hospital
Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, RenJi Hospital, Shenzhen University General Hospital, Sir Run Run Shaw Hospital, Tang-Du Hospital, First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Anhui Medical University, First Hospital of China Medical University, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital Xi'an Jiaotong University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, First Affiliated Hospital of Guangxi Medical University, The Affiliated Hospital of Qingdao University, Peking Union Medical College Hospital, Meng Chao Hepatobiliary Hospital of Fujian Medical University, The First Affiliated Hospital of University of Science and Technology of China, Cancer Hospital of Guangxi Medical University, Tongji Hospital, Zhejiang Provincial People's Hospital, The Second Affiliated Hospital of Kunming Medical University, Sichuan Provincial People's Hospital, Taizhou Hospital, Shaoxing People's Hospital, The First Hospital of Hebei Medical University
Conditions Intrahepatic Cholangiocarcinoma, PD1 Antibody, Lenvatinib, Gemox Chemotherapy
Enrollment 178 participants
Start Date 2021-01-20
Primary Completion 2025-04-30 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-04