OncoMatch/Clinical Trials/NCT06202001
Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients
Is NCT06202001 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab for metastatic colorectal cancer.
Treatment: Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage IV (AJCC 8th edition)
Metastatic disease required
Patients were clinically diagnosed with metastatic colorectal cancer based on computed tomography (CT) scan and magnetic resonance imaging (MRI) according to AJCC 8th edition.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: oxaliplatin-based chemotherapy — first-line
Patients have received oxaliplatin-based first-line chemotherapy with or without targeted therapy, immunotherapy or radiotherapy.
Cannot have received: irinotecan (irinotecan)
Exception: patients who previously received irinotecan while progressing during maintenance therapy are eligible
Patients who previously received irinotecan while disease progressed. However, patients who previously received irinotecan while progressing during maintenance therapy are eligible.
Lab requirements
Blood counts
Hemoglobin ≥90g/L; white blood cell count ≥3.5×10^9/L; absolute neutrophil count ≥1.5×10^9/L; platelet count ≥100×10^9/L
Kidney function
Serum creatinine ≤ ULN or creatinine clearance ≥60 ml/min
Liver function
Total serum bilirubin ≤1.5× ULN; AST/SGOT and ALT/SGPT ≤2.5× ULN
Appropriate organ function according to the following laboratory test values: Hemoglobin value ≥90g/L. White blood cell count ≥3.5×10^9/L. Absolute neutrophil count ≥1.5×10^9/L. Platelet count ≥100×10^9/L. Serum creatinine ≤ ULN or creatinine clearance ≥60ml/min. Total serum bilirubin ≤1.5× ULN. AST/SGOT and ALT/SGPT ≤2.5× ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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