drugset / Trial / NCT04506281
PD1 Antibody (Toripalimab), GEMOX and Lenvatinib Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
Phase 2
Unknown
128 enrolled
Shanghai Zhongshan Hospital
Minhang Hospital, Fudan University · collabShanghai Jinshan Hospital · collabShenzhen University General Hospital · collabXuhui Central Hospital, Shanghai · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized controlled, multi-center, open, phase II clinical study 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 Lenvatinib and GEMOX neoadjuvant treatment and the current clinical surgical treatment (traditional group).
Timeline
- Start
- 2020-08-10
- Primary completion
- 2021-08
- Completion
- 2023-08
Publications
- Results Shaib Y, El-Serag HB. The epidemiology of cholangiocarcinoma. Semin Liver Dis. 2004 May;24(2):115-25. doi: 10.1055/s-2004-828889.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1 g | — |
| Subject | Lenvatinib | Small molecule | 8 mg | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | — |