Actively Recruiting
Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study
Led by Ruijin Hospital · Updated on 2025-07-25
50
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a modified low-dose regimen of trifluridine/tipiracil combined with bevacizumab for patients with metastatic colorectal cancer that no longer responds to standard treatments. This phase II, single-center study aims to assess the effectiveness and safety of this treatment approach, addressing concerns about toxicity from standard doses. Participants will have previously received at least two chemotherapy regimens or been intolerant to them. The treatment involves taking trifluridine/tipiracil orally at 17.5 mg/m2 twice daily for 10 days, followed by 4 days off, in a 14-day cycle. Bevacizumab is given intravenously at 5 mg/kg on day 1 of each cycle, also every 14 days. This combined treatment will continue until the cancer progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants will undergo regular assessments to monitor disease progression and side effects. The main outcome measured is the progression-free survival rate at 6 months. Secondary outcomes include tracking adverse events, objective response rate up to 16 weeks, overall progression-free survival up to 60 months, and overall survival up to 100 months. Participants are monitored throughout treatment and followed for safety and effectiveness until the study ends.
CONDITIONS
Brief Title
Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 60 years, male or female
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic or advanced unresectable disease with at least two prior chemotherapy regimens or intolerance to last regimen
- With or without measurable lesions
- ECOG performance status 0 to 2 and expected survival over 3 months
- Adequate organ function to tolerate treatment: ANC 61.5x10^9/L, WBC 63.5x10^9/L, Platelets 65x10^9/L, Hemoglobin 80 g/L, ALT/AST 62.5x ULN (or 65x ULN if liver metastasis), Bilirubin 61.5x ULN, Creatinine 61.5x ULN
- Signed informed consent and willingness to follow study protocol
You will not qualify if you...
- Symptomatic metastases of the central nervous system
- Other primary cancers
- Uncontrolled comorbidities such as hypertension, thrombotic diseases, or chronic kidney disease
- Organ functions inadequate to tolerate study treatment
- Bowel obstruction or conditions affecting oral medication intake
- Allergy to study medications
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day cycles until disease progression, intolerable toxicity, or withdrawal of consent
Participants receive low-dose trifluridine/tipiracil orally twice daily for 10 days followed by 4 rest days in a 14-day cycle, combined with bevacizumab intravenously once on day 1 of each 14-day cycle. This treatment continues until disease progression, intolerable toxicity, or withdrawal of consent.
Visits every 2 weeks for treatment administration and monitoring
Trial Site Locations
Total: 2 locations
1
SanMing First Hospital
Sanming, China
Actively Recruiting
2
Ruijin Hospital
Shanghai, China
Actively Recruiting
Research Team
C
Chen-Fei Zhou, MD, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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