A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer
This study is a clinical study to explore the efficacy and safety of BL-B01D1+PD-1/PD-L1 monoclonal antibody in patients with advanced biliary tract cancer.
• Sign the informed consent form voluntarily and follow the protocol requirements;
• Gender is not limited;
• Age ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Patients with advanced biliary tract cancer confirmed by histology or cytology;
• Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG score 0-1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
⁃ No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
⁃ Organ function level must meet the requirements;
⁃ Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
⁃ Urinary protein ≤2+ or ≤1000mg/24h;
⁃ For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.