Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer

The goal of this clinical trial is to demonstrate the non-inferiority of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of progression free survival in patients with refractory metastatic colorectal cancer(mCRC) patients. It will also try to estimate the effect of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of OS, ORR, and DCR in patients with refractory mCRC. Other secondary objectives are to compare the safety and tolerance, and the impact on QoL of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil

Trial Details

NCT ID
NCT06992648
Phase
PHASE3
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Trifluridine/Tipiracil + Regorafenib
  • Trifluridine/tipiracil + bevacizumab
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • Sign Informed Consent Form (ICF) must be obtained during the screening visit, prior to the performance of any study procedure；
  • Male or female patient aged ≥18 years old;
  • Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded);
  • RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy;

For full eligibility, visit ClinicalTrials.gov.

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