NCT07510932: FIRST-K

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

Not yet recruiting Phase 2 Last updated 6 April 2026

What this trial tests

Phase 2 trial testing Fruquintinib in Colon Cancer in 88 participants. Not yet recruiting.

Timeline

1 May 2026

Primary endpoint
1 March 2027

1 September 2027

Quick facts

Lead sponsor	Korea University Anam Hospital
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	88
Start date	1 May 2026
Primary completion	1 March 2027
Estimated completion	1 September 2027

Drugs / interventions tested

• Fruquintinib — full drug profile →

Conditions studied

• Colon Cancer — all drugs for Colon Cancer →

Sponsor

Korea University Anam Hospital

Who can join

19 and older, any sex, with Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.