Colorectal Cancer
Conditions
Interventions
Experimental Arm: tislelizumab combined with bevacizumab and second-line chemotherapy
Sponsors
zhongshan hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years; 2) The ECOG 0 or 1; 3) Colorectal cancer with positive expression of PD-L1 and RAS mutation confirmed by histology and/or cytology has metastatic or recurrent foci that cannot be cured by surgery; 4) The first-line systematic anti-tumor treatment for mCRC has failed; chemotherapy drugs can include fluorouracil, oxaliplatin, irinotecan, such as XELOX, FOLFOX, FOLFIRI, FOLFOXIRI, XELIRI; targeted drugs can be combined or not, such as bevacizumab; 5) At least one measurable lesion defined according to RECIST version 1.1; 6) Patients with fertility must be willing to take effective contraceptive measures during the study period and = 120 days after the last administration of tiralizumab; The urine or serum pregnancy test results of female patients were negative within = 7 days before the first administration of the study drug; 7) Patients have fully understood this study and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) The following laboratory indicators are excluded: a) Absolute neutrophil count (ANC)1.5 times the upper limit of normal value (ULN); >2.5 times ULN in patients with liver metastasis; c) AST and ALT>2.5 times ULN, or ALT and/or AST>5 times ULN in patients with liver metastasis; d) Serum creatinine>1.5 times the upper limit of normal value (ULN), or creatinine clearance rate 1.5 times ULN (subject to the normal value of the clinical trial research center); f) Albumin 10 mg/day) or other immunosuppressive drugs within 14 days or less before the administration of the first study drug need not be excluded if they have used any of the following steroid treatment schemes at present or in the past: a) Adrenal replacement steroids (dose of prednisone or equivalent = 10 mg/day); b) Corticosteroids for local, eye, joint, nose or inhalation have very low systemic absorption; c) Short term (= 7 days) preventive use of corticosteroids (such as treatment of contrast agent allergy) or treatment of non autoimmune diseases (such as delayed type hypersensitivity caused by contact allergens); 6) Have a history of interstitial lung disease, non infectious pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension, etc.); 7) Clinically uncontrollable diarrhea; 8) Chronic or active infection requires systemic antimicrobial, antifungal or antiviral treatment, including tuberculosis infection. Patients with active tuberculosis infection history = 1 year before screening should also be excluded, unless proof can be provided that appropriate treatment has been completed; 9) Brain metastasis or leptomeningeal metastasis; 10) The clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the study drug; 11) There was a second clinically detectable primary malignant tumor at the time of enrollment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ); 12) Patients with poor control of diabetes or electrolyte disorders despite standard medical treatment; 13) Known history of human immunodeficiency virus infection; 14) Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers and HBV DNA higher than 500 IU/mL and patients with positive hepatitis C virus (HCV) RNA should be excluded. Inactive hepatitis B surface antigen (HBsAg) carrier
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;Disease control rate;overall survival;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| 6-month progression free survival (PFS) rate; | — |
Countries
China
Contacts
Public Contacttianshu liu
zhongshan hospital, Fudan University
Outcome results
None listed