BTCs
Conditions
Interventions
experimental group:1) QL1706:
During combination chemotherapy, give 5 mg/kg intravenously on day 1 of each cycle in 1 dosing cycle every 3 weeks.
During maintenance therapy, 5 mg/kg will be administe
3)Cisplatin:
During combination chemotherapy, 25mg/m2 given intravenously on days 1 and 8, every 3 weeks as 1 dosing cycle, up to a maximum of 6 cycles of treatment
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to any trial-related procedures; 2. Age > = 18 years; 3. Intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer confirmed by histology; 4. Unresectable locally advanced or recurrent metastatic BTC; 5. If it is unresectable or metastatic BTC at the initial diagnosis, it is necessary to have not received systemic anti-tumor therapy in the past; 6. If the patient is relapsed, it should be >6 months before radical surgery or neoadjuvant treatment 7. At least 1 measurable lesion confirmed by the investigator according to mRECIST 1.1; 8. ECOG score of 0-2 points; 9. For female patients of childbearing potential, the patient and/or partner agree to use a highly effective method of contraception; 10. Estimated survival >= 3 months; 11. Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load =1.5×10^9/L. b) Platelet >=100×10^9/L. c) Hemoglobin > = 90 g/L. d) Serum albumin > = 30 g/L. e) AST and ALT 1.5×ULN, the creatinine clearance (CLcr) calculated using the Cockcroft-Gault equation >=50 mL/min. h) Cardiac left ventricular ejection fraction (LVEF) >50%. i) Proteinuria =2+, 24-hour urine protein quantification should be performed, and =1g can be selected). j) International normalized ratio (INR) <=1.5, activated partial thromboplastin time (APTT) <=1.5× ULN. 14. Patients who in the opinion of the investigator can benefit.
Exclusion criteria
Exclusion criteria: 1. those who have been diagnosed with carcinoma of the jugular abdomen; 2. Received chemotherapy and molecularly targeted agents for the treatment of biliary malignancies in advanced stages; 3. Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other immunotherapy (e.g. anti-CTLA-4, anti-CD137, etc.); 4. Systemic infection or other serious infection requiring intravenous administration of antibiotics?7 days of treatment within 2 weeks prior to the first dose, or unexplained fever >38.5 degrees during the screening period, prior to enrollment (with the exception of fever due to oncologic causes in the subject, as determined by the investigator); 5. diagnosis of immunodeficiency or treatment with systemic steroids or any other form of immunosuppressive therapy or immunomodulators within 7 days prior to the first dose of study drug. 6. have symptomatic central nervous system metastases (CNS) metastases; 7. have an active or potentially relapsing autoimmune disease; 8. subjects with severe cardiovascular disease; 9. previous and/or current interstitial lung disease, pneumoconiosis, radiation pneumonitis that is assessed by the investigator to be clinically significant, and those with severely impaired lung function, etc., that may interfere with the detection and management of suspected drug-related pulmonary toxicity; 10. HIV-positive patients; known active tuberculosis within one year prior to the first dose of study treatment; known active syphilis infection; 11. patients with a history of other malignant tumors within 5 years prior to signing informed consent (except cured basal cell skin cancer, papillary thyroid cancer, etc.); 12. Those who have undergone major surgery or active ulcers or wounds that have not completely healed within 1 month of the first use of the study drug (excluding central venous cannulation, tumor tissue biopsy, or nasogastric tube intubation) 13. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation); 14. Live vaccination within 4 weeks prior to the first administration of the drug; 15. Participation in other clinical studies and use of other drugs for clinical trials within 4 weeks prior to the first administration of the drug; 16. women who are pregnant or breastfeeding; 17. patients known to have a history of psychotropic drug abuse, alcoholism, or drug addiction; previous history of definite neurologic or psychiatric disorders, including epilepsy or dementia or hepatic encephalopathy. 18. Known previous allergy of the patient to large protein preparations. Contraindications and allergies to any component of the test drug; 19. patients who, in the investigator's judgment, may increase the risks associated with the study, may interfere with the interpretation of the study results, etc. that the investigator considers unsuitable for enrollment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Duration of remission;TTR;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactKangsheng GU
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed