RecruitingPhase 2Phase 3NCT07554456

A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)

A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 for Injection in Combination With Tislelizumab With or Without 5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

90 participants

Start Date

Jun 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a registrational Phase II/III, randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with tislelizumab ± 5-FU in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5-Fluorouracil, a drug called BL-B01D1, and others for people with esophageal squamous cell carcinoma. 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.

DRUGTislelizumab

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG5-Fluorouracil

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGCisplatin

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGPaclitaxel

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT07554456


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