Evaluating BL-B01D1 with Tislelizumab With or Without 5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-Line Treatment for Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the combination of BL-B01D1 with tislelizumab, with or without 5-Fluorouracil, compared to platinum-based chemotherapy plus tislelizumab for patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma. This Phase IIIII randomized, controlled, open-label, multicenter trial aims to assess the efficacy and safety of these treatments as first-line therapy for this condition. Participants receive one of three treatment regimens delivered by intravenous infusion every 3 weeks in cycles BL-B01D1 with tislelizumab and 5-Fluorouracil BL-B01D1 with tislelizumab alone or cisplatin with paclitaxel or 5-Fluorouracil plus tislelizumab. Those who show clinical benefit may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons require stopping. During the study, participants undergo evaluations including tumor response assessments, survival monitoring, and safety checks. Researchers measure overall survival up to approximately 24 months as the primary outcome, along with secondary outcomes such as response rates, disease control, duration of response, progression-free survival, adverse events, and immune responses. The expected survival time for participants is at least 3 months, with follow-up continuing through the study period until 2028.

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)