Biliary Tract Malignant Tumors
Conditions
Interventions
Experimental group:benmelstobart combined with gemcitabine and cisplatin
Experimental group: benmelstobart combined with anlotinib
Sponsors
The Second Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Age: 18~75 years old; Both men and women are welcome 2. Histopathologically confirmed inoperable untreated gallbladder cancer or intrahepatic and extrahepatic cholangiocarcinoma, with at least one measurable lesion according to RECIST v1.1; Tissue samples must be provided for biomarker analysis, preferably newly obtained tissues, and patients who cannot provide newly obtained tissues can provide 5-8 archival 5um thick paraffin slices. 3. ECOG score: 0-1 points; 4. Expected survival >=12 weeks; 5. Normal function of major organs, that is, meeting the following criteria: (1) Routine blood examination: 1)HB>=90 g/L; (No blood transfusion within 14 days) 2)ANC>=1.5×10^9/L; 3)PLT>=80×10^9/L; (2) Biochemical examination: 1) ALB>=30g / L; (No ALB transfusion within 14 days) 2) ALT and AST=60ml/min; 6. Subjects voluntarily join this study, sign the informed consent form, and are able to comply with the visits and related procedures specified in the protocol; 7. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age must take effective contraceptive measures throughout the treatment period and for 6 months of the treatment period;
Exclusion criteria
Exclusion criteria: First-line exclusion criteria 1. Proven allergy to TQB-2450 components; 2. Patients who have participated in clinical trials of other drugs within 4 weeks; 3. Known history of primary immunodeficiency 4. Histology-confirmed ampullary carcinoma Second-line exclusion criteria 1. Proven allergy to anlotinib hydrochloride and/or its excipients and TQB-2450 components; 2. Uncontrolled hypertension, grade I or above coronary heart disease, arrhythmia and cardiac insufficiency; Those with urine protein >=++ or 24-hour urine protein quantification greater than 1.0g; 3. Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency; 4. Previous treatment with anti-VEGFR small molecule TKI, PD-L1 monoclonal antibody; 5. Known history of primary immunodeficiency; 6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease Control Rate;Overall survival; | — |
Countries
China
Contacts
Public ContactHai Yan Liu
The Second Affiliated Hospital of Shandong First Medical University
Outcome results
None listed