Unresectable extrahepatic biliary carcinoma
Conditions
Interventions
Experimental group:Terelizumab combined with lenvatinib and GEMOX (gemcitabine + oxaliplatin)
Sponsors
The First Medical Center of the People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years who underwent surgery for the first time, no gender limit; 2. Hilar cholangiocarcinoma, gallbladder carcinoma or distal cholangiocarcinoma as determined by imaging, laboratory or pathological examination; 3. No systemic treatment prior to study participation; 4. TNM stage for ? to ? period; 5. ECOG PS score 0 - 1; 6. The function of major organs is normal, without serious abnormal blood, heart, lung, liver, kidney, bone marrow and other functional diseases and immune deficiency. Laboratory tests meet the following requirements: (1) Hemoglobin >=90 g/L (no blood transfusion within 14 days); (2) Absolute neutrophil count >=1.5x10^9/L; (3) Platelet count >=90x10^9/L; (4) Total bilirubin <=2.5 times the upper limit of normal value; (5) Alanine aminotransferase and ASpartate aminotransferase <=2.5 times the upper limit of normal value; (6) Creatinine <=1.25 times the upper limit of normal value; (7) Thyroid stimulating hormone (TSH) <=1 times ULN (if abnormal, T3 and T4 levels should be investigated at the same time, if T3 and T4 levels are normal, can be enrolled); (8) International normalized ratio of prothrombin time (INR) <=1.5 and partial thromboplastin time (APTT) <=1.5 times the upper limit of normal in patients who had not received anticoagulant therapy. Patients receiving full or parenteral anticoagulants were allowed to enter the clinical trial as long as the anticoagulant dose was stable for at least 2 weeks before entering the clinical trial and the results of the coagulation test were within the limits of the local treatment; 7. Women of childbearing age were required to have a negative pregnancy test (serum or urine) within 14 days before enrollment and to voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last administration of the study drug; For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and up to 8 weeks after the last administration of the study drug; 8. The patient voluntarily participated and signed the informed consent; 9. The compliance is expected to be good, and the efficacy and adverse reactions can be followed up according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who were treated with PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly treated with another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137); 2. Had used any other study drug within 4 weeks before enrollment; 3. Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (included after hormone replacement therapy)); Patients with complete remission of childhood asthma who did not need any intervention in adulthood or vitiligo could be included, but patients requiring medical intervention with bronchodilators were not included; 4. Have innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (HCV antibody positive, and HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C; 5. Severe infection (e.g., requiring intravenous antibiotic, antifungal, or antiviral medication) within 4 weeks before the first dose, or unexplained fever >38.5? during the screening period/before the first dose; 6. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Live attenuated vaccine was administered within 4 weeks before the first dose or planned during the study period; 8. Have had or been associated with other systemic malignancies in the last 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and ovarian cancer); 9. Known allergy to any test drug; 10. Pregnant and lactating patients, reproductive subjects are not willing to take effective contraceptive measures; 11. Suffering from uncontrollable mental illness; 12. Other circumstances deemed inappropriate for inclusion by the investigator. If the patient has central nervous system metastases, severe laboratory abnormalities, family or social factors may affect the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of radical resection after conversion therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;major pathologic response;overall survival;progress free survival ;incidence of adverse events; | — |
Countries
China
Contacts
Public ContactLiu Rong
The First Medical Center of the People's Liberation Army General Hospital
Outcome results
None listed