Overview

D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer

Status:
NOT_YET_RECRUITING

Trial end date:
2027-12-31

Target enrollment:

Participant gender:

Summary

The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS). Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.

Phase:

PHASE3

Details

Lead Sponsor:

InnoPharmax Inc.

Treatments:

Capecitabine