RecruitingPhase IIEN originalColorectal cancerMetastatic / advanced

Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek 18-75 lat
  • Potwierdzony histologicznie rak jelita grubego z przerzutami
  • Nowotwór bez mutacji w genach NRAS, KRAS i BRAF
  • Co najmniej jeden widoczny guz do zmierzenia
  • Ogólny stan zdrowia pozwalający na aktywność (0-1 w skali ECOG)
  • Spodziewana długość życia co najmniej 12 tygodni
  • Wcześniejsze leczenie fluoro-pirymidyną, oksaliplatyną i irynotekanem (bez efektu)
  • Wystarczająca funkcja wątroby, nerek i szpiku kostnego

✗ Disqualifies

  • Wcześniejsze leczenie inhibitorami tyrozyny kinazy VEGFR (np. regorafenibem)
  • Uczestnictwo w innym badaniu klinicznym w ostatnich 4 tygodniach
  • Niekontrowana nadciśnienie tętnicze (ciśnienie >140/90 mmHg)
  • Problemy z wchłanianiem leków lub brak możliwości połykania tabletek
  • Aktywny wrzód żołądka, zapalenie jelita grubego lub krwawienie związane z nowotworem
  • Pozytywny test krwi w kale bez potwierdzenia źródła krwawienia
  • Otrzymanie chemioterapii w ciągu 4 tygodni przed włączeniem do badania

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
July 24, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/26/2026.

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