a study of bl-b01d1+pd-1/pd-l1 monoclonal antibody in patients with advanced biliary tract cancer

Conditions: Advanced Biliary Tract Cancer

Summary: 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.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. gender is not limited; 3. age ≥18 years old and ≤75 years old; 4. expected survival time ≥3 months; 5. patients with advanced biliary tract cancer confirmed by histology or cytology; 6. patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for pd-l1 testing and other testing; 7. at least one measurable lesion meeting the recist v1.1 definition was required; 8. ecog score 0-1; 9. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 10. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. organ function level must meet the requirements; 12. coagulation function: international normalized ratio (inr) ≤1.5×uln, and activated partial thromboplastin time (aptt) ≤1.5×uln; 13. urinary protein ≤2+ or ≤1000mg/24h; 14. 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. exclusion criteria: 1. patients with active central nervous system metastases; 2. who had participated in any other clinical trial within 4 weeks before the trial dose; 3. received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug; 4. had undergone major surgery (investigator-defined) within 4 weeks before the first dose; 5. had received immunotherapy and developed grade ≥3 irae or grade ≥2 immune-related myocarditis; 6. use of immunomodulatory drugs within 14 days before the first dose of study drug; 7. systemic corticosteroids or immunosuppressive agents were required within 2 weeks before the study administration; 8. pulmonary disease grade ≥3 according to nci-ctcae v5.0; a history of ild/pulmonary inflammation requiring steroid treatment; 9. severe systemic infection occurred within 4 weeks before screening; 10. patients at risk for active autoimmune disease or with a history of autoimmune disease; 11. other malignant tumors within 5 years before the first dose; 12. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or hepatitis c virus infection; 13. poorly controlled hypertension by two antihypertensive drugs with different mechanisms; 14. diabetic patients with poor glycemic control; 15. had a history of severe cardiovascular and cerebrovascular diseases; 16. previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation; 17. subjects with clinically significant bleeding or significant bleeding tendency within the preceding 4 weeks were screened; 18. patients with massive or symptomatic effusions or poorly controlled effusions; 19. imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart; 20. unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 21. prior treatment with an adc drug with a topoisomerase i inhibitor as a toxin; 22. patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of the trial drug; 23. the cumulative dose of anthracyclines \> 360 mg/m2 in previous (new) adjuvant therapy; 24. pregnant or lactating women; 25. who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 26. the investigator did not consider it appropriate to apply other criteria for participation in the trial.