clinical trial · NCT07582315
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)
Sichuan Baili Pharmaceutical Co., Ltd.·phase3·recruiting·n = 538
Biliary Tract CancerBL-B01D1OxaliplatinCalcium levofolinateFluorouracilIrinotecan Hydrochloride LiposomeIrinotecan HydrochlorideCapecitabine
brief 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.
started
Jun 29, 2026
primary completion
Dec 1, 2028
completion
Dec 1, 2028
last updated
Jul 24, 2026
detailed description
In this trial, the experimental group receives BL-B01D1 administered once every 3 weeks (Q3W), while the control group receives the investigator's choice of protocol.
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol