biliary tract carcinoma
Conditions
Interventions
cohort 1:Camrelizumab(200mg,d1)+gemcitabine(800mg/m2,d1,d8)+oxaliplatin(100mg/m2,d1),Q3W,4-6 cycles, followed by camrelizumab(200mg,d1,Q3W)+fluzooparib(150mg,bid), up to 2 years
cohort 2:Camrelizumab(200mg,d1)+gemcitabine(800mg/m2,d1,d8)+oxaliplatin(100mg/m2,d1),Q3W,4-6 cycles, followed by camrelizumab(200mg,d1,Q3W)+apatinib(250mg,qd), up to 2 years
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathological or cytological diagnosis of unresectable advanced or metastatic biliary malignancy, including cholangiocarcinoma and gallbladder cancer, excludes ampullary carcinoma. 2. Aged 18-75, both sexes; 3. Expected survival time >= 3 months; 4. ECOG score 0-1; 5. There was at least one measurable lesion according to RECIST 1.1; 6. No previous local or systemic treatment for biliary malignancies, and if the subject has received adjuvant therapy, tumor recurrence or disease progression must have occurred at least 12 months after the completion of the last adjuvant therapy; 7. The main organs function well, that is, the relevant examination indexes within 14 days before enrollment meet the following requirements: hemoglobin >= 90 g/L (no blood transfusion within 14 days); Neutrophil count>1.5 x 10^9/L Platelet count >= 100 x 10^9/L Total bilirubin = 60 ml/min (Cockcroft Gault formula); Left ventricular ejection fraction (LVEF) >= 50% assessed by cardiac Doppler ultrasound; 8. Sign the informed consent form with good compliance, and the family members agree to cooperate in the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. History of other primary malignancies other than: a. Malignancies that have been treated for radical treatment and have no known active disease >= 5 years prior to initial administration and have a low potential risk of recurrence b. Adequately treated non-melanoma skin cancer or malignant freckles with no evidence of disease c. Adequately treated carcinoma in situ with no evidence of disease; 2. Participated in other drug clinical trials within 4 weeks; 3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [other than diverticular disease], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [e.g., granulomatous vasculitis, Gray's disease, rheumatoid arthritis, pituitaritis, and uveitis]). Exceptions to this criteria are (1) Patients with vitiligo or alopecia; (2) Patients with stable hypothyroidism after hormone replacement therapy (e.g., after Hashimoto's thyroiditis); (3) Patients with any chronic skin disease that does not require systemic therapy; (4) Patients who have not had the active disease in the last 5 years may be included, but may only be included after consulting the study physician e. People with celiac disease that can be controlled by diet alone; 4. Subjects with active hepatitis B (defined as positive hepatitis B virus surface antigen [HBsAg] detection and HBV-DNA detection value >= 2000 IU/ML) or hepatitis C (defined as positive hepatitis C virus surface antibody [HCsAb] detection and HCV-RNA detection); 5. Uncontrollable complications, including but not limited to Persistent or active infections (other than those described above for HBV or HCV), symptomatic congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active ILD, severe chronic GI disease with diarrhea, or having a condition that may limit compliance with study requirements and result in a significant increase or impact on the risk of AE Mental/social problems of the subject's ability to provide written informed consent; 6. For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive during the study treatment period and for 6 months after the study treatment period ends; Serum or urine pregnancy tests must be negative within 7 days prior to study enrollment and must be non-lactating. Male subjects: patients who should be surgically sterilized or who agree to use a medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period; 7. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8. Pleural effusion or abdominal effusion with clinical symptoms requiring clinical intervention; 9. In the judgment of the investigator, there is a serious concomitant disease that endangers the patient's safety or affects the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;Objective response rate;Disease Control Rate;Overall survival;Safty; | — |
Countries
China
Contacts
Public ContactXiaofeng Sun
Jiangsu Cancer Hospital
Outcome results
None listed