OncoMatch/Clinical Trials/NCT07724223
Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC
Is NCT07724223 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Fruquintinib plus Cetuximab-beta for metastatic colorectal cancer (crc).
Treatment: Fruquintinib plus Cetuximab-beta — This study aims to evaluate the effectiveness and safety of combining fruquintinib (an oral anti-angiogenesis drug) with cetuximab-beta (an anti-EGFR antibody) in patients with RAS wild-type metastatic colorectal cancer who have already failed at least two lines of standard treatments. Standard therapies for metastatic colorectal cancer often include fluorouracil, oxaliplatin, and irinotecan. However, many patients eventually experience disease progression, and treatment options become limited. Fruquintinib and cetuximab-beta work through different mechanisms: fruquintinib blocks tumor blood vessel growth, while cetuximab-beta blocks EGFR-related cancer cell growth signals. Using these two drugs together may provide additional benefit for patients whose cancer no longer responds to other treatments. This study will enroll 46 patients who meet the eligibility criteria. All participants will take fruquintinib by mouth once daily (3 weeks on and 1 week off) and receive cetuximab-beta by intravenous infusion every 2 weeks. Treatment will continue until the cancer progresses or side effects become intolerable. Doctors will monitor tumor changes every 8 weeks using CT or MRI scans and will also collect blood samples over time to measure circulating tumor DNA (ctDNA), which may help track how the cancer responds to treatment. Safety will be assessed through physical exams, lab tests, and monitoring of side effects. The main goal of the study is to determine the objective response rate (ORR)-how many patients experience measurable tumor shrinkage. Secondary goals include progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety outcomes.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF wild-type
Required: KRAS wild-type
Required: NRAS wild-type
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: oxaliplatin-based therapy
Prior treatment with oxaliplatin- and irinotecan-based therapy, or failure of at least two prior standard regimens
Must have received: irinotecan-based therapy
Prior treatment with oxaliplatin- and irinotecan-based therapy, or failure of at least two prior standard regimens
Must have received: fluoropyrimidine
Prior treatments must have included fluoropyrimidine, oxaliplatin, and irinotecan (with or without bevacizumab or cetuximab)
Cannot have received: VEGFR tyrosine kinase inhibitor (regorafenib)
Prior treatment with VEGFR tyrosine kinase inhibitors (e.g., regorafenib)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 80 × 10⁹/L; Hemoglobin ≥ 8 g/dL
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN; AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN in liver metastasis)
Adequate organ function within 7 days prior to enrollment: * ANC ≥ 1.5 × 10⁹/L * Platelets ≥ 80 × 10⁹/L * Hemoglobin ≥ 8 g/dL * Total bilirubin ≤ 1.5 × ULN * AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN in liver metastasis) * Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min * INR ≤ 1.5 or APTT ≤ 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07724223 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior VEGFR tyrosine kinase inhibitor disqualifies patients from enrollment.
Does this trial require BRAF?
Yes, BRAF wild-type is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages