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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(PANKU-BTC01)

trialsTrialRecruiting

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 3 trial of Oxaliplatin and Capecitabine in biliary tract cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.

Also called: PANKU-BTC01

Overview Connected4

Overview

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) is a phase 3 interventional study registered as NCT07582315 by Sichuan Baili Pharmaceutical Co., Ltd., with 538 participants planned, started 2026-06-29 and due to reach its primary completion in 2028-12. Interventions recorded: BL-B01D1, Oxaliplatin, Calcium levofolinate, Fluorouracil, Irinotecan Hydrochloride Liposome and Irinotecan Hydrochloride.

Setting

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)

Phase

Phase 3

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Registry

Started

2026-06-29

Enrolled

538 enrolled

Connected

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cancers

Biliary tract cancer (cholangiocarcinoma)

drugs

ApprovedOral fluoropyrimidine prodrug (antimetabolite)

Capecitabine · Xeloda

ApprovedThird-generation platinum (DACH-platinum)

Oxaliplatin · Eloxatin

companies

SystImmune / Sichuan Biokin

Evidence strength49/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
538 enrolled+14
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-18 · Jude Gomila · Trial acronyms for registry records · diff · file

Sources & links

ClinicalTrials.gov NCT07582315

Data

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Cancers

Biliary tract cancer (cholangiocarcinoma)

Products

Oxaliplatin
Capecitabine

Companies

SystImmune / Sichuan Biokin

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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