Actively Recruiting
Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC
Led by Meng Qiu · Updated on 2025-01-22
66
Participants Needed
2
Research Sites
166 weeks
Total Duration
On this page
Sponsors
M
Meng Qiu
Lead Sponsor
B
Beijing Xisike Clinical Oncology Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Our previous studies have shown that the combination of raltitrexed and S-1 -/+ bevacizumab is effective and provides a significant survival benefit in patients with metastatic colorectal cancer (mCRC) who are refractory to standard treatments. This study aims to evaluate the efficacy and safety of combining Fruquintinib with S-1 and raltitrexed in these patients.
CONDITIONS
Official Title
Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with metastatic colorectal adenocarcinoma confirmed by pathology or cytology
- Expected survival of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Previously treated with fluoropyrimidine, irinotecan, and oxaliplatin chemotherapy that failed
- At least 2 weeks since last chemotherapy (1 week for oral drugs) or more than 4 weeks since radiotherapy, with measurable lesions outside radiotherapy areas
- At least one measurable tumor lesion 1 cm or larger by spiral CT scan per RECIST 1.1
- Laboratory tests within 1 week before enrollment meet required blood counts and organ function levels
- No prior use of raltitrexed or S-1 (or DPD enzyme inhibitors) in colorectal cancer treatment
- Signed informed consent
You will not qualify if you...
- Unable to take oral medications
- Previously treated with small molecule tyrosine kinase inhibitors (TKIs)
- Severe liver or kidney failure, or heart attack within past 3 months
- History of other cancers within past 5 years except cured cervical carcinoma in situ or basal cell skin cancer
- History of inflammatory bowel disease, extensive bowel resection, chronic diarrhea, or intestinal obstruction
- Severe uncontrolled medical conditions or acute infections with fever above 38°C
- Symptomatic brain or leptomeningeal metastases unless treated and stable for over 6 months with recent negative imaging
- Clinically significant uncontrolled pleural effusion or ascites despite treatment
- Pregnant or breastfeeding, or unwilling to use contraception if of reproductive potential
- Known allergy to raltitrexed, S-1, Fruquintinib, or their components
- Investigator deems participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sichuan University West China Hospital
Chengdu, Sichuan, China, 610044
Actively Recruiting
2
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
M
Meng Qiu, MD.
CONTACT
W
Weibing C Leng, PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here