Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

Recruiting now · Phase 2

Conditions studied: Colo-rectal Cancer, Third-line and Beyond Therapy, TAS 102, Bevacizumab

In brief

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.

Key facts

Study ID

NCT07085169

Run by

Ruijin Hospital

People needed

50

Starts

2025-08-01

Expected to finish

2028-08-01

Last updated by the study team

2025-07-25

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SanMing First Hospital — Sanming, China (enrolling)
• Ruijin Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.