Biliary tract malignancy
Conditions
Interventions
Experimental group: Iparomlimab and Tuvonralimab+Gemcitabine+Oxaliplatin
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>= 18 years, male or female; 2. Biliary tract malignancy confirmed by histology or cytology; 3. Unresectable locally advanced or recurrent metastatic BTC; 4. No previous systemic anti-tumor therapy for advanced/metastatic disease. Patients who have previously received adjuvant/neoadjuvant chemotherapy or have received definitive chemoradiotherapy for advanced disease, such as disease progression or recurrence at least 6 months between the end of the last drug treatment, are allowed to be enrolled in this study; 5. At least 1 measurable lesion confirmed by mRECIST v1.1; 6. ECOG score is 0-2 points; 7. For female patients of childbearing potential, the patient and/or partner agree to use a highly effective method of contraception; 8. Expected survival >=3 months 9. The functional level of vital organs must meet the following requirements within 3 days before the first dose (supportive therapy such as any blood components and cell growth factors is not allowed within 14 days before the first dose); (1) Absolute neutrophil count >=1.5×10^9/L; (2) Platelets>=90×10^9/L; (3) Hemoglobin >=90 g/L; (4)) Serum albumin>=30 g/L; (5)) AST and ALT 1.5×ULN, the creatinine clearance (CLcr) calculated by the Cockcroft-Gault equation >=50 mL/min; (8) Cardiac left ventricular ejection fraction (LVEF) > 50%. (9) Proteinuria < 2+ (when urine protein =2+, 24-hour urine protein quantification should be performed, and <=1g can be selected); (10) International normalized ratio (INR) < = 1.5; Activated partial thromboplastin time (APTT) < = 1.5× ULN; 10. Patients who are considered to be able to benefit by the investigator.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with ampullary carcinoma, pathologically or histologically confirmed special types of BTC, such as small cell carcinoma, neuroendocrine carcinoma, etc.; 2. Received chemotherapy and molecularly targeted drugs for the treatment of advanced biliary tract cancer; 3. Previous or concurrent malignant tumors, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Tumors such as microscopic gastric stromal tumors and other early tumors that do not affect the patient's life in the short term after radical treatment can be excluded; 4. Previous treatment with the following: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other immunotherapy (such as anti-CTLA-4, anti-CD137, etc.); 5. Systemic infection or other serious infection requiring intravenous antibiotics > 7 days of treatment within 2 weeks before the first dose, or unexplained fever >38.5 degrees during screening and before enrollment (except for fever caused by tumor causes in the judgment of the investigator); 6. Diagnosed with immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy or immunomodulator therapy within 7 days prior to the first dose of study drug. 7. Symptomatic central nervous system metastases (CNS) metastases, meningeal metastases, and meningeal metastases; 8. Active or likely relapsed autoimmune disease; 9. Subjects with severe cardiovascular and cerebrovascular diseases; 10. Previous and/or current interstitial lung disease, pneumoconiosis, radiation pneumonia, chronic obstructive pulmonary disease assessed by the investigator as clinically significant, and severely impaired lung function that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; 11. HIV-positive patients; Known active tuberculosis within one year prior to first dose of study treatment; Known active syphilis infection; 12. Pleural effusion, abdominal effusion or pericardial effusion with clinical symptoms requiring clinical intervention; 13. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation); 14. Vaccinated with live vaccine within 4 weeks before the first dose; 15. Those who have participated in other clinical studies and used other clinical trial drugs within 4 weeks before the first dose; 16. Pregnant or lactating women; 17. Known patient has a history of psychotropic substance abuse, alcoholism or drug abuse; Previous history of definite neurological or psychiatric disorders, including epilepsy or dementia or hepatic encephalopathy, etc.; 18. Known patient has a previous allergy to macromolecular protein preparations. Contraindications and allergies to any component of the trial drug; 19. Active or previous history of definite inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea); 20. Major surgical procedures or severe trauma within 30 days before the first dose, or major surgical procedures planned within 30 days after the first dose (as determined by the investigator); 21. Current uncontrolled comorbid disease, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease, or gastritis, or psychiatric illness/social conditions that would limit the subject's compliance with the study requirements or affect the subject's ability to provide written informed consent; 22. Any arteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Duration of remission;Time to Response;Safety; | — |
Countries
China
Contacts
Public ContactMingxi Wang
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed