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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Biliary Tract Cancer (BTC)
Interventions
DRUG

D07001-Softgel Capsules

D07001-softgel capsule is an oral gemcitabine.

DRUG

Placebo

Placebo has the same excipient with D07001-softgel but without active pharmaceutical ingredients (APIs)

COMBINATION_PRODUCT

Capecitabine

Capecitabine, a fluoropyrimidine carbamate derivative, is an oral tumor activator and selective cytotoxic agent.

Trial Locations (1)

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

InnoPharmax Inc.

INDUSTRY

NCT06622057 - D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer | Biotech Hunter | Biotech Hunter