Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer

Phase 2 Unknown 80 enrolled Zhejiang Cancer Hospital

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the efficacy and safety of Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer

Timeline

Start: 2020-01-01
Primary completion: 2021-01
Completion: 2022-01

Publications

Li J, Zhou S, Xu X, Zheng Q, Zhang F, Luo C, Li D, Sun X, Han Z, Wu W, Yan J, Shao Y, Zhang Y, Wu B, Wei Q, Wang X, Zhou Y, Sun W, Xu Q, Ying J. Sintilimab and anlotinib with gemcitabine plus cisplatin in advanced biliary tract cancer: SAGC a randomized phase 2 trial. Nat Commun. 2025 Jul 1;16(1):5559. doi: 10.1038/s41467-025-60119-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Catequentinib	Small molecule	10 mg	Oral
Subject	Sintilimab	Monoclonal antibody	200 mg	Intravenous
Background	Cisplatin	Other / unclassified	25 mg/m2	—
Background	Gemcitabine	Small molecule	1000 mg/m2	—

Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer

Summary

Timeline

Publications

Drugs

Indications