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Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients

StatusUnknown
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 2, 2024 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Apr 2024); last known: Recruiting
  2. Study description expanded, about 167 wordsv2 See this version in full on ClinicalTrials.gov ↗
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06202001
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Metastatic Colorectal Cancer
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov