Actively Recruiting
Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-05-28
302
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to demonstrate the non-inferiority of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of progression free survival in patients with refractory metastatic colorectal cancer(mCRC) patients. It will also try to estimate the effect of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of OS, ORR, and DCR in patients with refractory mCRC. Other secondary objectives are to compare the safety and tolerance, and the impact on QoL of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in patients with refractory mCRC.
CONDITIONS
Official Title
Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before any study procedure
- Male or female aged 18 years or older
- Histologically confirmed unresectable adenocarcinoma of the colon or rectum
- Known RAS status from tumor biopsy
- Previous treatment for advanced colorectal cancer including fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF antibody, and/or anti-EGFR antibody for RAS wildtype
- Measurable or non-measurable disease per RECIST 1.1
- Ability to swallow oral tablets
- Estimated life expectancy of at least 12 weeks
- ECOG performance status 0 or 1
- Adequate organ function based on blood tests within 7 days prior to randomization
- Negative pregnancy test for women of childbearing potential within 7 days prior to randomization
- Agreement to use effective birth control during study and for 6 months after last dose
You will not qualify if you...
- Prior treatment with trifluridine/tipiracil or tyrosine kinase inhibitors for advanced colorectal cancer
- Pregnancy, breastfeeding, or possibility of becoming pregnant during the study
- Anticancer therapy within 4 weeks before randomization
- Unresolved severe non-blood toxicities from prior cancer therapy (except hair loss and skin pigmentation)
- Symptomatic, unstable brain metastases or need for increasing steroids for CNS disease
- Severe or uncontrolled active infections
- History or active interstitial lung disease, pneumonitis, or pulmonary hypertension
- Active significant hepatitis including Hepatitis B or C
- Known HIV infection
- Uncontrolled high blood pressure or symptomatic arrhythmia
- Recent serious arterial blood clots or heart attack within 6 months
- Major surgery within 4 weeks prior to randomization or not fully recovered
- Radiotherapy less than 2 weeks before randomization except short-course for symptom relief
- Other significant medical conditions or other cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yinuo TAN, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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