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.
Voluntarily sign the informed consent form and agree to follow the protocol requirements;
No gender restriction;
Age ≥18 years and ≤75 years at the time of signing the informed consent form;
Expected survival time ≥3 months;
Patients with esophageal squamous cell carcinoma whose pathology indicates the presence of non-squamous carcinoma components;
Use of immunomodulatory drugs within 2 weeks prior to the first study drug administration;
Prior use of an ADC drug whose small-molecule toxin is a topoisomerase I inhibitor;
Patients with esophageal squamous cell carcinoma who are suitable for curative-intent local therapy;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator