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A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus01)

StatusActive, Not Recruiting
PhasePhase 3
Started2024-03-19
View on ClinicalTrials.gov ↗

Amendment history

2026-07-22
Study Status v6
Primary completion moved earlier: 2026-05 → 2025-10-17
Completion pushed: 2026-05 → 2027-06
2026-04-15
Study Identification, Study Status v5
Study title+19 characters
[...] h Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus01)
2025-11-13
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 488→confirmed 497
Study sitesdetails revised at 1 of 1 site
2025-04-30
2 amendments v2-v3
2 re-verifications since 2024-07-16, no change to tracked fields
2024-03-27
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-04→confirmed 2024-03-19
Study sitesdetails revised at 1 of 1 site
2024-03-05
Original filing
This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy.
Trial Details
NCT Number NCT06304974
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Esophageal Squamous Cell Carcinoma
Enrollment 497 participants
Start Date 2024-03-19
Primary Completion 2025-10-17 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-23