Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

NCT07085169 | Recruiting Phase 2

• 1 other identifier: TAS-102/2025-No.412
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 6-month progression-free survival rate

  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.

  6 months

Secondary Outcomes (4)

• Adverse events

  through study completion, an average of 1 year

• Objective response rate

  up to 16 weeks

• Progression free survival

  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

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

Study Arms (1)

Experimental

EXPERIMENTAL

Trifluridine/tipiracil 17.5 mg/m2 bid. po. d1-10, q2w Bevacizumab 5mg/kg ivgtt. d1 q2w

Drug: Trifluridine/tipiracil (TAS-102) plus bevacizumab

Interventions

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.

Experimental

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (2)

SanMing First Hospital

Sanming, China

RECRUITING

Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Trifluridine; tipiracil; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Chen-Fei Zhou, MD, Ph.D

CONTACT

+86-21-64370045; zcf12085@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: All patients will receive 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.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 25, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

CN (2)