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NCT06622057 · ClinicalTrials.gov record · last posted 2026-07-30

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

StatusRecruiting
PhasePhase 3
Started2026-06-09
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-07-09
Enrollment increased: 195 → 240 participants
2026-07-09
Primary completion pushed: 2027-12-31 → 2028-12-31
2026-07-09
Completion pushed: 2027-12-31 → 2028-12-31
2026-06-12
Recruitment opened
Trial Details
NCT Number NCT06622057
Lead Sponsor InnoPharmax Inc.
Conditions Biliary Tract Cancer (BTC)
Enrollment 240 participants
Start Date 2026-06-09
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30