Low-dose trifluridine/tipiracil plus bevacizumab for metastatic colorectal cancer
Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study
This will try a lower-dose trifluridine/tipiracil plus bevacizumab regimen for people with metastatic colorectal cancer who have progressed after at least two prior treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy, bevacizumab |
| Locations | 2 sites (Sanming and 1 other locations) |
| Trial ID | NCT07085169 on ClinicalTrials.gov |
What this trial studies
This Phase II prospective study gives patients with refractory metastatic colorectal adenocarcinoma a modified low-dose schedule of trifluridine/tipiracil (17.5 mg/m2 orally twice daily on days 1–10 of a 14‑day cycle) combined with bevacizumab (5 mg/kg IV on day 1 of each 14‑day cycle). Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent. The trial will collect safety and efficacy data including response rates, progression-free survival, and detailed toxicity profiles. The study aims to see if the lower-dose schedule maintains cancer control while reducing treatment-related side effects.
Who should consider this trial
Good fit: Patients over 60 with histologically confirmed metastatic or unresectable colorectal adenocarcinoma who progressed after at least two standard chemotherapy regimens and who meet performance-status (ECOG 0–2) and organ-function requirements are ideal candidates.
Not a fit: Patients with symptomatic central nervous system metastases, other active primary cancers, uncontrolled comorbidities, or inadequate organ function are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, the regimen could provide similar disease control with fewer side effects and improved tolerability for older or frail patients.
How similar studies have performed: Trifluridine/tipiracil plus bevacizumab has shown benefit in refractory colorectal cancer and dose-modification approaches have shown promising toxicity reductions, but this specific low-dose 14‑day schedule is less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age over 60 years old, male and female 2. histologically confirmed adenocarcinoma of the colon or rectum 3. patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen 4. with or without measurable lesions 5. ECOG 0 to 2, expected survival time over 3 months 6. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN. 7. Signed informed consent and willing to follow the study protocol Exclusion Criteria: 1. symptomatic metastases of central nervous system 2. other primary malignancies 3. uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease 4. organ functions that cannot tolerate study treatment 5. bowel obstruction or other conditions affecting oral administration 6. allergic to study medication 7. other conditions that patients are unsuitable for this study assessed by the investigators
Where this trial is running
Sanming and 1 other locations
- SanMing First Hospital — Sanming, China (Recruiting)
- Ruijin Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Chen-Fei Zhou, MD, Ph.D
- Email: zcf12085@rjh.com.cn
- Phone: +86-21-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.