Low-dose trifluridine/tipiracil plus bevacizumab for metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.