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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 and PD-1/PD-L1 Monoclonal Antibody Therapy(PANKU-BTC01)

NCT07582315 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2026-05-22

No results posted yet for this study

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 and PD-1/PD-L1 antibody therapy.

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Oxaliplatin

Administration by intravenous infusion for a cycle of 2 weeks.

DRUG

Calcium levofolinate

Administration by intravenous infusion for a cycle of 2 weeks.

DRUG

Fluorouracil

Administration by intravenous infusion for a cycle of 2 weeks.

DRUG

Irinotecan Hydrochloride Liposome

Administration by intravenous infusion for a cycle of 2 weeks.

DRUG

Irinotecan Hydrochloride

Administration by intravenous infusion for a cycle of 2 weeks.

DRUG

Capecitabine

Oral administration for a cycle of 2 weeks.

Sponsors & Collaborators

  • Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sichuan Baili Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

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 NCT07582315 on ClinicalTrials.gov