Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Ref
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/tip
| Condition(s) | Colorectal Cancer Metastatic, Colorectal Cancer Recurrent |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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 + bevacizumab in patients with refractory mCRC. |
| Who can participate | Inclusion Criteria: 1. Sign Informed Consent Form (ICF) must be obtained during the screening visit, prior to the performance of any study procedure； 2. Male or female patient aged ≥18 years old; 3. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded); 4. RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; 5. Prior treatment regimens for the treatment of advanced colorectal cancer must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody for RAS wildtype patients; 6. Has measurable or non-measurable disease as defined by RECIST version 1.1; 7. Is able to swallow oral tablets; 8. Est |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2025-04-01 |
| NCT ID | NCT06992648 |
| Official listing | https://clinicaltrials.gov/study/NCT06992648 |