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Clinical trialNCT06622057RecruitingPhase 3Interventional

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

SponsorInnoPharmax Inc.Enrollment240Biliary Tract Cancer (BTC)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

    Li-Tzong Chen
    Not, yet, recruiting
United States
  • the University of Arizona Cancer Center

    Tucson, Arizona, United States

    Rachna Shroff, MD
    Recruiting
  • Mount Sinai Medical Center

    Miami Beach, Florida, United States

    Mike Cusnir
    Recruiting
  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, United States

    Amit Mahipal
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

D07001-Softgel CapsulesPlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
9 Jun 2026
Primary completion
31 Dec 2028
Completion
31 Dec 2028
Last update posted
30 Jul 2026
Registered enrollment
240
Registry id
NCT06622057
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.