RecruitingPhase 2NCT07085169

Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study

Sponsor

Ruijin Hospital

Enrollment

50 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Colo-rectal Cancer Bevacizumab Third-line and Beyond Therapy TAS 102

Summary

This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Eligibility

Min Age: 60 Years

Inclusion Criteria7

age over 60 years old, male and female
histologically confirmed adenocarcinoma of the colon or rectum
patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen
with or without measurable lesions
ECOG 0 to 2, expected survival time over 3 months
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.
Signed informed consent and willing to follow the study protocol

Exclusion Criteria7

symptomatic metastases of central nervous system
other primary malignancies
uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease
organ functions that cannot tolerate study treatment
bowel obstruction or other conditions affecting oral administration
allergic to study medication
other conditions that patients are unsuitable for this study assessed by the investigators

Interventions

DRUGTrifluridine/tipiracil (TAS-102) plus bevacizumab

Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This is a single-arm study with all patients receiving these two drugs.