Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K)

Sponsor
Korea University Anam Hospital
Study ID
NCT07510932
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fruquintinib — DRUG
    Fruquintinib

Study Details

Background Patients with metastatic colorectal cancer who have progressed after treatment with oxaliplatin- and irinotecan-based chemotherapy, as well as anti-EGFR monoclonal antibodies (cetuximab or panitumumab) according to RAS mutation status, or anti-angiogenic agents (bevacizumab, ramucirumab, or aflibercept), have limited therapeutic options in the third-line setting. The phase III SUNLIGHT trial evaluating TAS-102 (trifluridine/tipiracil) in combination with bevacizumab demonstrated promising outcomes, with a median progression-free survival (PFS) of 5.6 months and a median overall survival (OS) of 10.8 months. However, approximately 30% of patients in that study had not previously received bevacizumab during first- or second-line treatment, indicating that a proportion of patients had not been fully exposed to current standard therapies for metastatic colorectal cancer. Therefore, there remains an unmet need to evaluate additional therapeutic strategies in patients who have received optimal prior standard treatments. This study aims to evaluate the efficacy and safety of fruquintinib as a third-line treatment in this population. Hypothesis Proactive and comprehensive supportive care will not only help manage fruquintinib-related toxicities (e.g., hypertension, hand-foot syndrome, proteinuria, and fatigue), but also enable patients to maintain treatment, thereby potentially prolonging progression-free survival (PFS). Study Design This is a multicenter, single-arm, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with supportive care in patients with metastatic colorectal cancer who are intolerant to second-line standard chemotherapy. All subjects will receive fruquintinib treatment in combination with supportive care. Supportive care refers to medical interventions aimed at preventing and managing adverse events associated with fruquintinib, including but not limited to hypertension, proteinuria, diarrhea, fatigue, and hand-foot syndrome.

Key Dates

First listed
Apr 6, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fruquintinib

Primary Outcome Measure

Progression-free survival [ Time Frame: From initiation of IP drug to progression or death, up to 24 weeks ]

Central Contacts

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