OncoMatch/Clinical Trials/NCT06992258
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
Is NCT06992258 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Fruquintinib+ Lonsurf (trifluridine and tipiracil) and Fruquintinib for colorectal cancer.
Treatment: Fruquintinib+ Lonsurf (trifluridine and tipiracil) · Fruquintinib — A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 proficient
Mismatch repair proficient (MMRp) status documented by local IHC testing
Required: MSH6 proficient
Mismatch repair proficient (MMRp) status documented by local IHC testing
Required: MLH1 proficient
Mismatch repair proficient (MMRp) status documented by local IHC testing
Required: PMS2 proficient
Mismatch repair proficient (MMRp) status documented by local IHC testing
Required: KRAS mutation status documented
RAS and BRAF status documented
Required: NRAS mutation status documented
RAS and BRAF status documented
Excluded: BRAF V600 mutation
Patients with BRAF V600 mutations
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine — advanced/metastatic
Prior treatment with fluoropyrimidine ... for the treatment of advanced or metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen
Must have received: oxaliplatin — advanced/metastatic
Prior treatment with ... oxaliplatin ... for the treatment of advanced or metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen
Must have received: irinotecan — advanced/metastatic
Prior treatment with ... irinotecan ... for the treatment of advanced or metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen
Must have received: VEGF inhibitor (bevacizumab) — advanced/metastatic
Prior treatment with ... bevacizumab (unless contraindicated) ... for the treatment of advanced or metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen
Must have received: EGFR inhibitor (cetuximab, panitumumab) — advanced/metastatic
cetuximab/panitumumab (for RAS-wild type disease)
Cannot have received: VEGFR inhibitor (regorafenib, fruquintinib)
Prior treatment with regorafenib ... or fruquintinib
Cannot have received: antimetabolite (trifluridine-tipiracil, TAS-102)
Prior treatment with ... trifluridine-tipiracil (TAS-102)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 70 × 10^9/L; Hemoglobin ≥ 9 g/dL in the previous week
Kidney function
Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault Equation (or similar formula) or as calculated using a timed urine collection
Liver function
Serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if Gilbert's disease); AST and ALT < 3 x ULN (≤ 5 x ULN with liver metastases)
Cardiac function
Corrected QT interval using the Fridericia method > 470 msec excluded; NYHA class 3 or 4 CHF or LVEF < 50% excluded; uncontrolled arrhythmia or any ventricular arrhythmia requiring treatment excluded
Adequate hematologic and end organ function, defined by the following laboratory results obtained within 72 hours prior to first dose of study drug treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University · New Haven, Connecticut
- Mount Sinai Cancer Research Program · Miami Beach, Florida
- Orlando Health Cancer Institute · Orlando, Florida
- Rutgers Cancer Institute · New Brunswick, New Jersey
- NYU Langone Health · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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