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NCT Number: NCT07085169

Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

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.

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Key information

Conditions

Colo-rectal Cancer Bevacizumab Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site TAS 102 Third-line and Beyond Therapy

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SanMing First Hospital, Sanming, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trifluridine/tipiracil (TAS-102) plus bevacizumab

Drug

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 outcomes

  1. 6-month progression-free survival rate

    Time frame: 6 months

    Defined as the proportion of patients who remain free from disease progression (as per RECIST criteria) or death for at least 6 months following initiation of study treatment.

Secondary outcomes

  1. Adverse events

    Time frame: through study completion, an average of 1 year

  2. Objective response rate

    Time frame: up to 16 weeks

  3. 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

  4. Overall survival

    Time frame: From date of enrollment until the date of death from any cause, assessed up to 100 months

Study contacts

Contact information is provided by the study sponsor or research team.

Chen-Fei Zhou, MD, Ph.D

CONTACT

[email protected]

+86-21-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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