drugset / Trial / NCT04669496
Phase II-III Clinical Trial of PD1 Antibody (Toripalimab), Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
Phase 2/3
Active not recruiting
178 enrolled
Shanghai Zhongshan Hospital
Cancer Hospital of Guangxi Medical University · collabEastern Hepatobiliary Surgery Hospital · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabFirst Affiliated Hospital of Guangxi Medical University · collabFirst Affiliated Hospital of Wenzhou Medical University · collabFirst Hospital of China Medical University · collabMeng Chao Hepatobiliary Hospital of Fujian Medical University · collabPeking Union Medical College Hospital · collabRenJi Hospital · collabShanghai Jiao Tong University Affiliated Sixth People's Hospital · collabShanghai Public Health Clinical Center · collabShaoxing People's Hospital · collabShenzhen University General Hospital · collabSichuan Provincial People's Hospital · collabSir Run Run Shaw Hospital · collabTaizhou Hospital · collabTang-Du Hospital · collabThe Affiliated Hospital of Qingdao University · collabThe First Affiliated Hospital of Anhui Medical University · collabThe First Affiliated Hospital of University of Science and Technology of China · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First Hospital of Hebei Medical University · collabThe Second Affiliated Hospital of Kunming Medical University · collabTongji Hospital · collabXinhua Hospital, Shanghai Jiao Tong University School of Medicine · collabZhejiang Provincial People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-01-20
- Primary completion
- 2025-04-30
- Completion
- 2026-12
Publications
- Background Shaib Y, El-Serag HB. The epidemiology of cholangiocarcinoma. Semin Liver Dis. 2004 May;24(2):115-25. doi: 10.1055/s-2004-828889.
- Background Shen WF, Zhong W, Xu F, Kan T, Geng L, Xie F, Sui CJ, Yang JM. Clinicopathological and prognostic analysis of 429 patients with intrahepatic cholangiocarcinoma. World J Gastroenterol. 2009 Dec 21;15(47):5976-82. doi: 10.3748/wjg.15.5976.
- Background Cho SY, Park SJ, Kim SH, Han SS, Kim YK, Lee KW, Lee SA, Hong EK, Lee WJ, Woo SM. Survival analysis of intrahepatic cholangiocarcinoma after resection. Ann Surg Oncol. 2010 Jul;17(7):1823-30. doi: 10.1245/s10434-010-0938-y. Epub 2010 Feb 18.
- Background Fisher SB, Patel SH, Kooby DA, Weber S, Bloomston M, Cho C, Hatzaras I, Schmidt C, Winslow E, Staley CA 3rd, Maithel SK. Lymphovascular and perineural invasion as selection criteria for adjuvant therapy in intrahepatic cholangiocarcinoma: a multi-institution analysis. HPB (Oxford). 2012 Aug;14(8):514-22. doi: 10.1111/j.1477-2574.2012.00489.x. Epub 2012 May 22.
- Background Yamashita Y, Taketomi A, Morita K, Fukuhara T, Ueda S, Sanefuji K, Iguchi T, Kayashima H, Sugimachi K, Maehara Y. The impact of surgical treatment and poor prognostic factors for patients with intrahepatic cholangiocarcinoma: retrospective analysis of 60 patients. Anticancer Res. 2008 Jul-Aug;28(4C):2353-9.
- Shi GM, Huang XY, Liang F, Liang X, Dong R, Ye QH, Gao Q, Ji Y, Yu ZP, Zhai WL, Lu JC, Li XW, Liu FB, Wang K, Yang W, Zhang JL, Hu ZQ, Qiu SJ, Wang XY, Yang XR, Sun HC, Shi YH, Ding ZB, Liu WR, Huang XW, Huang C, Shen YH, Sun J, He YF, Peng YF, Xu Y, Zou JJ, Zhou J, Fan J; ZSAB Study Group. Neoadjuvant GOLP in Resectable High-Risk Intrahepatic Cholangiocarcinoma. N Engl J Med. 2026 Mar 5;394(10):983-995. doi: 10.1056/NEJMoa2513918.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | — |