Actively Recruiting
Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC
Led by Ruijin Hospital · Updated on 2025-07-25
50
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 60 years old, male and female
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic or advanced unresectable disease with two or more previous chemotherapy regimens or intolerance to last regimen
- Presence or absence of measurable lesions
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with expected survival over 3 months
- Adequate organ function including ANC 1.5x10^9/L, WBC 3.5x10^9/L, platelets 75x10^9/L, hemoglobin 80 g/L, ALT/AST 2.5x ULN (or 5x ULN if liver metastasis), bilirubin 1.5x ULN, and creatinine 1.5x ULN
- Signed informed consent and willingness to follow the study protocol
You will not qualify if you...
- Symptomatic central nervous system metastases
- Other primary malignancies
- Uncontrollable comorbidities such as hypertension, thrombotic diseases, or chronic kidney disease
- Organ functions insufficient to tolerate study treatment
- Bowel obstruction or conditions affecting oral medication intake
- Allergy to study medications
- Any other condition deemed unsuitable for study participation by investigators
AI-Screening
AI-Powered Screening
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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
CONTACT
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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