Tislelizumab Plus Cetuximab and Irinotecan Comparing the Third-line Standard-of-care Selected by Researchers in the Treatment of Ras Wild-type Recurrent Refractory Metastatic Colorectal Cancer: A Multicenter, Randomized, Controlled Clinical Trial
This is a multicenter, randomized, controlled, phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab and irinotecan（group A） compared to third-line regimens selected by researchers（group B） in the treatment of Ras wild-type recurrent and refractory metastatic colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment inthe past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 87 patients will be randomly assigned to group A and group B according to 2:1. The enrollment time is expected to be 12 months and the follow-up is expected to be 24 months.
• Age≥18years；
• The ECOG PS score was≤1;
• Ras wild-type colorectal cancer diagnosed by histology and/or cytology has metastasis or recurrence that cannot be cured by surgery;
• Have received at least second-line systemic anti-tumor treatments for mCRC and failed, in which chemotherapy drugs can include fluorouracil, oxaliplatin or irinotecan; with or without targeted drugs, such as cetuximab or bevacizumab;
• At least one measurable lesion defined according to RECIST version 1.1;
• Patients with fertility must be willing to take efficient contraceptive measures during the study period and ≥ 120 days after the last administration of drugs; female patients have negative urine or serum pregnancy test results ≤ 7 days before the first administration of the study drugs;
• Fully understand and voluntarily sign the informed consent form;
• Organ function is good ≤ 7 days before randomization, as shown in the following:
• a.Blood transfusion or growth factor support within 2 weeks before enrollment are not allowed to meet the enrollment criteria: i. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9 / L; ii.Platelet count≥ 75 × 10\^9 / L; iii.Hemoglobin≥9g/dL or 90g / L or 5.6mmol/l; b. Serum total bilirubin ≤1.5 times the upper limit of normal value(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); e. Partial prothrombin time (APTT) or prothrombin time (PT) ≤1.5 times ULN; f. Albumin ≥30g / L;