At a glance
ClinicalIndex Comparison Record- ✓Age ≥ 18 years, any gender
- ✓Metastatic colorectal adenocarcinoma confirmed by pathological histology or cytology
- ✓Expected survival time ≥ 12 weeks
- ✓Previously treated with fluoropyrimidine, irinotecan, and oxaliplatin chemotherapy that failed
- ✕Unable to take oral medications
- ✕Prior treatment with small molecule TKI drugs
- ✕Severe hepatic or renal insufficiency or recent myocardial infarction (within 3 months)
- ✕History of other malignancies within past 5 years except cured cervical carcinoma in situ and basal cell carcinoma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06427005Phase 2RecruitingUpdate OverdueUpdated 17mo ago · Completion was 10mo agoFruquintinib Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: a Phase II Study
In Brief
A Phase 2 clinical trial evaluating Fruquintinib, S-1, and 1 other intervention for Fruquintinib and 2 related conditions. Currently recruiting, targeting 66 participants across 2 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
Fruquintinib 5 mg daily for 14 days followed by a 7-day break
S-1 80-120 mg daily for 14 days, followed by a 7-day break
raltitrexed 3 mg/m² on day 1, with a maximum dose of 5 mg