drugset / Trial / NCT06622057
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-06-09
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D07001 | Unknown | 60 mg | Oral |
| Subject | D07001 | Unknown | 100 mg | Oral |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |