Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

Launched by RUIJIN HOSPITAL · Jul 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with advanced colorectal cancer that has spread and has not responded to previous treatments. The trial is testing a combination of two medicines: trifluridine/tipiracil, which is taken as a pill, and bevacizumab, given through a vein. The goal is to see if this combination is safe and effective at slowing down the cancer or controlling its symptoms.

The study is open to adults over 60 years old who have colorectal cancer that cannot be removed by surgery and who have already tried at least two other chemotherapy treatments without success. Participants should be well enough to handle the treatment, meaning their blood counts and organ functions are within acceptable ranges, and they should not have serious other health problems like brain metastases or bowel blockages. During the trial, patients will take the trifluridine/tipiracil pills twice daily for 10 days every two weeks and receive a bevacizumab infusion once every two weeks. The treatment will continue until the cancer worsens, side effects become too difficult, or the patient chooses to stop. This study aims to offer a potential new option for patients with limited treatment choices.

Gender

ALL

Eligibility 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