MedTrace Logo

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

NCT06622057 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2026-04-14

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • InnoPharmax Inc.

    lead INDUSTRY

Principal Investigators

  • Andy Huang · InnoPharmax Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06622057 on ClinicalTrials.gov