Colorectal cancer
Conditions
Interventions
Arm A:tislelizumab combined with cetuximab and irinotecan
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years; 2.The ECOG PS score of the eastern United States cancer cooperation group was 0 or 1; 3.Ras wild-type colorectal cancer diagnosed by histology and / or cytology has metastasis or recurrence that cannot be cured by surgery; 4.Have received at least second-line systemic anti-tumor treatment for MCRC and failed, in which chemotherapy drugs can include fluorouracil, oxaliplatin and irinotecan, such as XELOX, FOLFOX, FOLFIRI, folfoxiri and xeliri; targeted drugs can be combined or not, such as cetuximab and bevacizumab; 5.At least one measurable lesion defined according to RECIST version 1.1; 6.Patients with fertility must be willing to take efficient contraceptive measures during the study period and = 120 days after the last administration of tirelizumab; female patients have negative urine or serum pregnancy test results = 7 days before the first administration of the study drug; 7.Fully understand this study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.The following laboratory indicators belong to the exclusion criteria: a.Absolute neutrophil count (ANC)1.5 times the upper limit of normal value (ULN); Patients with liver metastasis > 2.5 times ULN; c.Aspartate aminotransferase (AST) and alanine aminotransferase (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 1.5 times ULN (subject to the normal value of clinical trial and Research Center); f.Albumin 10 mg / day) or other immunosuppressive drugs within = 14 days 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.Local, ocular, intra-articular, intranasal or inhaled corticosteroids with very low systemic absorption; c.Short term (= 7 days) prophylactic use of corticosteroids (e.g. for the treatment of contrast medium allergy) or for the treatment of non autoimmune diseases (e.g. delayed type hypersensitivity caused by contact allergens); 6.there are 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 infections require systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection. Patients with a history of active tuberculosis infection = 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.Clinically significant pleural effusion, pericardial effusion or ascites need to be drained for many times within 2 weeks before the first administration of the study drug; 11.There is a clinically detectable second primary malignant tumor at the time of enrollment, or there have been other malignant tumors in the past 5 years (except fully treated skin basal cell carcinoma or cervical carcinoma in situ); 12.despite the use of standard care, patients with poor control of diabetes or poor electrolyte control are still in control. 13.Known history of human immunodeficiency virus infection; 14.Untreated patients with chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA higher than 500 IU / ml and patients with positive hepatitis C virus (HCV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Progression-free survival (PFS);Overall survival (OS);safety; | — |
Countries
China
Contacts
Public ContactLiu Tianshu
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed