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)
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 unresectable, locally advanced recurrent or metastatic first-line esophageal squamous cell carcinoma;
• Must have at least one measurable target lesion as defined by RECIST v1.1;
• Must provide archived tumor tissue specimens from the primary or metastatic lesion within the past 3 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
⁃ No severe cardiac dysfunction; left ventricular ejection fraction ≥50%;
⁃ Organ function levels must meet the specified requirements;
⁃ Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);
⁃ Urine protein ≤1+ or \<1000 mg/24h;
⁃ For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must be negative, and the patient must not be breastfeeding; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.