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Recruiting NCT07085169

Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trifluridine/tipiracil (TAS-102) plus bevacizumab.
Who it may be relevant to
Registry conditions: Colo-rectal Cancer, Third-line and Beyond Therapy, TAS 102, Bevacizumab. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

The treatment options as third-line therapy for metastatic colorectal cancer patients are limited. Trifluridine/tipiracil (TAS-102) plus bevacizumab has been approved in colorectal cancer for patients who are refractory to or intolerant of standard chemotherapy. However, the toxicity of trifluridine/tipiracil at standard dose a clinical concerned issue. Modifications of dose and treatment cycle of trifluridine/tipiracil have been investigated, and show promising effect to reduce the toxicity. In this study, patients with refractory metastatic colorectal cancer who have disease progression after at least 2 standard regimens will be treated with low-dose trifluridine/tipiracil 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 regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Interventions

  • Drug Trifluridine/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.

Primary outcome measures

  • 6-month progression-free survival rate [Time frame: 6 months]
Secondary outcome measures (4)
  • Adverse events [Time frame: through study completion, an average of 1 year]
  • Objective response rate [Time frame: up to 16 weeks]
  • Progression free survival [Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
  • Overall survival [Time frame: From date of enrollment until the date of death from any cause, assessed up to 100 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • SanMing First Hospital — Sanming
  • Ruijin Hospital — Shanghai

Identifiers

NCT: NCT07085169 · TAS-102/2025-No.412

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗