Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients
Trial Parameters
Brief Summary
In mCRC, response to second-line chemotherapy is limited, and few treatment options are available. It is urgent to design an optimal second-line treatment regimen to improve the response rate and prolong the survival of patients with mCRC. Several studies preliminarily demonstrated that irinotecan, TAS-102 plus bevacizumab regimen could bring promising efficacy with a tolerable safety profile for patients with mCRC as a second-line treatment. This phase I/II study was aimed to determine the recommended phase II dose (RP2D) of the combination of TAS-102, irinotecan, and bevacizumab for future clinical trials in patients with mCRC refractory to both fluoropyrimidine and oxaliplatin and to evaluate its safety and preliminary efficacy.
Eligibility Criteria
Inclusion Criteria: 1. Colorectal adenocarcinoma confirmed histologically or histopathologically. 2. Patients were clinically diagnosed with metastatic colorectal cancer based on computed tomography (CT) scan and magnetic resonance imaging (MRI) according to AJCC 8th edition. 3. Patients have received oxaliplatin-based first-line chemotherapy with or without targeted therapy, immunotherapy or radiotherapy. 4. Age ≥18 and ≤70. 5. ECOG physical status score is 0 or 1, and no obvious deterioration within 2 weeks prior to use on Day 1 of Cycle 1. 6. Appropriate organ function according to the following laboratory test values: 1. Hemoglobin value ≥90g/L. 2. White blood cell count ≥3.5\*109/L. 3. Absolute neutrophil count ≥1.5\*109/L. 4. Platelet count ≥100\*109/L. 5. Serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance ≥60ml/min. 6. Total serum bilirubin ≤1.5\* upper normal limit (ULN). 7. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5\*