At a glance
ClinicalIndex Comparison Record- ✓Colorectal adenocarcinoma confirmed histologically or histopathologically
- ✓Metastatic disease confirmed by CT/MRI per AJCC 8th edition
- ✓Prior oxaliplatin-based first-line chemotherapy with or without targeted therapy, immunotherapy or radiotherapy
- ✓Age 18–70 years
- ✕Non-adenocarcinoma histology (squamous, neuroendocrine, adenosquamous, other types)
- ✕Prior irinotecan with disease progression (eligible if progression during maintenance therapy only)
- ✕Hypersensitivity to irinotecan, TAS-102, or bevacizumab
- ✕Unable to swallow or GI tract integrity issues; malabsorption; inability to take oral medication
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06202001Phase 2RecruitingUpdate OverdueUpdated 26mo ago · Completion was 9mo agoPhase I/II Study of Irinotecan Plus Trifluridine/Tipiracil (TAS-102) in Combination With Bevacizumab as a Second-Line Therapy for Patients With Metastatic Colorectal Cancer (mCRC)
In Brief
A Phase 2 clinical trial evaluating Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab for Metastatic Colorectal Cancer. Currently recruiting, targeting 70 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
This study followed a classic 3+3 design, in which patients received escalating doses of TAS-102 (20, 25, 30, or 35 mg/m2/dose, administered twice daily for days 1-5) and irinotecan (135, 150, 165, or 180 mg/m2 on day 1) with a fixed dose of bevacizumab (5 mg/kg on day 1), repeated every 14 days.