Advanced biliary tract tumors
Conditions
Interventions
Experimental group:Toripalimab in Combination with GEMOX
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patients included in the study must meet all of the following conditions: 1) Age >= 18 years and = 80 points within 7 days before enrollment. 3) Un-treated advanced or metastatic biliary system tumors (cystic carcinoma, intrahepatic and extrahepatic bile duct cancer), or patients who have undergone radical surgery + adjuvant therapy previously, the first discovery of metastatic lesions must be >= 6 months after the last administration of adjuvant therapy, and the pathological type is adenocarcinoma. 4) At least 1 measurable lesion is present in the CT/MRI examination according to the RECIST1.1 standard. 5) Within 7 days before enrollment, the blood routine and biochemical indicators of the patients meet the following standards: a. Hemoglobin >= 90g/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelets >= 100×10^9/L (patients must not have received blood transfusion or growth factor support within 14 days after blood sample collection); b. ALT, AST = 60ml/min/1.73m^2 (Appendix 3); e. Serum albumin >= 30g/L; f. International normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN, unless the patient is receiving anticoagulation treatment and the PT value is within the expected treatment range of the anticoagulant; g. Activated partial thromboplastin time (aPTT) <= 1.5 times ULN. 6) Able to comply with the protocol during the study period. 7) Provide written informed consent before entering the study, and the patient has understood that they can withdraw from the study at any time without any loss. 8) Women with reproductive capacity (Appendix 6) must have a negative urine or serum pregnancy test within 7 days before enrollment, and must agree to take effective contraceptive measures during the study and for at least 120 days after the last administration (including chemotherapy drugs and teprotumumab); 9) Unsterilized men must agree to take effective contraceptive measures during the study period and for at least 120 days after the last administration.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following conditions will be excluded: 1) Have received previous treatment for biliary tract tumors, including radiotherapy, chemotherapy, and immunotherapy (except for patients whose disease recurs more than 6 months after the end of previous adjuvant therapy). 2) Have active autoimmune diseases or have a history of autoimmune diseases that may recur (Appendix 4). Note: The following diseases are not excluded and can be included in the further screening: a. Controlled type 1 diabetes b. Hypothyroidism (if controlled by hormone replacement therapy) c. Controlled celiac disease d. Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia) e. Other diseases that are expected not to recur without external triggering factors. 3) Have any active malignant tumors within 2 years, except for specific cancers being studied in this trial and locally recurrent cancers that have been cured (such as surgically removed basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ). 4) Have uncontrollable and frequently draining pleural effusion, pericardial effusion or ascites within 14 days before enrollment (cellular examination of the effusion is allowed for confirmation). 5) Have gastrointestinal bleeding within 2 weeks before enrollment, or are judged by the investigator to have a high risk of bleeding. 6) Have had gastrointestinal perforation and/or fistula within 6 months before enrollment. 7) Have lost >= 20% of body weight within 2 months before enrollment. 8) Have clinically significant lung diseases: interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, etc. 9) Have uncontrollable systemic diseases including diabetes, hypertension, etc. 10) Have severe chronic or active infections that require systemic antibacterial, antifungal or antiviral treatment, including tuberculosis, HIV infection, etc. 11) Patients with untreated chronic hepatitis B or chronic HBV carriers with HBV DNA > 1000 IU/mL, or HCV RNA positive should be excluded. Non-active hepatitis B surface antigen (HBsAg) carriers, stable hepatitis B patients (HBV DNA upper limit of normal (ULN). 15) Are allergic to any components of the study medication. 16) Have undergone allogeneic stem cell transplantation or organ transplantation. 17) Patients who needed system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival period;Overall survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor markers; | — |
Countries
China
Contacts
Public ContactZhong Haijun
Zhejiang Cancer Hospital
Outcome results
None listed