Activity of Regorafenib in Combination With Chemotherapy in Patients With Advanced Biliary Tract Cancer

Summary

This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib administered in combination with mGEMOX in patients with advanced biliary tract cancer.

Timeline

Start

2014-09

Primary completion

2019-12

Completion

2019-12

Outcome

Missed primary endpoint

paper Median PFS (7.2 vs7.8 months; P = .825) and overall survival (15.1 vs 13.5 months; P = .356) were similar between arms. PMID 40542585 ↗

paper Combining regorafenib and mGEMOX is feasible as first-line treatment for BTC but did not increase PFS as expected in the phase II cohort. PMID 40542585 ↗

Publications

• Results Blanc JF, Bouattour M, Gauthier L, Deshayes E, Guillemard S, Touchefeu Y, Portales F, Borg C, Harguem L, Guimbaud R, Mineur L, Ychou M, Mazard T, Assenat E. Regorafenib plus modified gemcitabine-oxaliplatin in patients with advanced biliary tract cancer. The randomized phase Ib/II BREGO study. Oncologist. 2025 Jun 4;30(6):oyaf080. doi: 10.1093/oncolo/oyaf080.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Regorafenib	Small molecule	80 mg	Oral
Subject	Regorafenib	Small molecule	120 mg	Oral
Subject	Regorafenib	Small molecule	160 mg	Oral
Background	Gemcitabine	Small molecule	900 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	80 mg/m2	Intravenous

Indications