RecruitingPhase 3NCT07582315

A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

538 participants

Start Date

Jun 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BL-B01D1, a drug called Calcium levofolinate, and others for people with biliary tract cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGOxaliplatin

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGCalcium levofolinate

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGFluorouracil

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGIrinotecan Hydrochloride Liposome

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGIrinotecan Hydrochloride

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGCapecitabine

Oral administration for a cycle of 2 weeks.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT07582315


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