Advanced cholangiocarcinoma
Conditions
Interventions
PD1 monoclonal antibody in combination with multimodality radiotherapy group:PD1 monoclonal antibody in combination with multimodality radiotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histopathological diagnosis of advanced metastatic cholangiocarcinoma, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma; 2. Failure or intolerance of standard treatment; 3. Aged 18-75 years at the date of signing the informed consent; 4. ECOG score 0-2; 5. Child Pugh Grade A; 6. At least >= 1 measurable lesion according to RECIST V1.1, or >= 1 measurable lesion with definite progression after local treatment (based on RECIST V1.1); at least one radiotherapy-capable lesion and radiographically capable of evaluating distant effects were also present; 7. Life expectancy >= 12 weeks; 8. Controlled hepatitis B subjects must meet the following criteria to be eligible for the study: they must have received HBV antiviral therapy for at least 1 month prior to the first dose of the study drug and must have an HBV viral load of less than 2000 IU/mL (104 copies/mL) prior to the first dose. Subjects receiving anti-HBV therapy with viral load less than 2000 IU/mL (104 copy numbers/mL) should remain on the same treatment throughout the study; 9. Major organ functions within 28 days before treatment meet the following criteria: (1) Blood routine examination standard (no blood transfusion within 14 days): hemoglobin (HB) >= 80 g/L; neutrophil absolute number (ANC) >= 1.5 x 10^9/L; platelet (PLT) >= 80 x 10^9/L; (2) Biochemical tests should meet the following criteria: total bilirubin (TBIL) = 60 ml/min; (3) Coagulation tests should meet the following standards: international standardized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN; activated partial thrombin time (APTT) <= 1.5 x ULN (if the patient is on anticoagulant therapy, as long as PT and APTT are within the expected treatment range); (4) Thyroid function: T3 and T4 levels were normal after drug treatment; 10. Women of childbearing age should agree to use contraceptive methods (such as iUDS, pregnancy pills or condoms) during the study period and 120 days after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment; 11. Subject consented and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. History of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and carcinoma of the thyroid papilla; 2. Known allergic reaction to the active ingredient of PD1 or any excipients; 3. Patients who had previously received combined radiotherapy and immunotherapy; 4. Symptomatic CNS metastasis; 5. Patients who have received potent CYP3A4 inhibitor treatment within one week before enrollment, or CYP3A4 inducer treatment within two weeks before enrollment; 6. New York Heart Association grade III-IV congestive heart failure; 7. Ischemic cardiovascular events occurred within 1 year before the start of treatment; 8. Undergoing systemic immunosuppressive therapy; 9. Participate in clinical trials of other interventional drugs within 4 weeks before the first administration; 10. Subjects requiring systematic treatment with corticosteroids (more than 10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks prior to initial use of the study drug; 11. Vaccinated with anti-tumor vaccine or live vaccine within 4 weeks before the first administration of the study drug; 12. Major surgery or severe trauma within 4 weeks prior to the first use of the study drug; 13. Severe infection (CTCAE greater than grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and complications of infection requiring hospitalization; baseline chest imaging suggests active lung inflammation, signs and symptoms of infection within 2 weeks prior to initial use of the study drug, or the need for oral or intravenous antibiotic therapy (excluding prophylactic use of antibiotics); 14. Have a history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone, and type 1 diabetes treated with stable doses of insulin can be included; patients with vitiligo or recovered childhood asthma/allergies who do not need any intervention as adults are excluded; 15. Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ and bone marrow transplants; 16. Patients who were found to have active tuberculosis infection through medical history or CT examination, or who had active tuberculosis infection history within 1 year prior to enrollment, or who had active tuberculosis infection history before 1 year but without formal treatment; 17. The subject has active hepatitis (HBV DNA >= 2000 IU/ mL or 10000 copies/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of analysis method); 18. Known history of psychotropic drug abuse, alcoholism and drug abuse; 19. Pregnant or lactating women; 20. There are medical histories, diseases, treatments, or laboratory abnormalities that may interfere with the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Duration of remission;Adverse reactions; | — |
Countries
China
Contacts
Public ContactLi Zhiping
West China Hospital of Sichuan University
Outcome results
None listed