NIPH Clinical Trials Search

SECOND-FIT

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Colorectal cancer
Date of first enrollment	28/04/2026
Target sample size	70
Countries of recruitment
Study type	Interventional
Intervention(s)	Fruquintinib Fruquintinib is administered orally at a dose of 5 mg once daily for 3 consecutive weeks, followed by a 1-week drug-free period. This 4-week period is defined as one treatment cycle, and treatment is repeated until discontinuation. Dose reduction may be performed as appropriate according to the patient condition.

Outcome(s)

Primary Outcome	Progression-free survival (PFS)
Secondary Outcome	Overall survival (OS) Objective response rate (ORR) Disease control rate (DCR) Incidence of adverse events Geriatric functional assessment Biomarker analysis (Liquid biopsy)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Histopathological diagnosis from surgical or biopsy specimen confirming adenocarcinoma (papillary, tubular, poorly differentiated, mucinous, signet-ring cell, medullary) according to the 9th edition of the Japanese Classification of Colorectal Carcinoma. 2. Primary tumor located in the cecum (C), ascending colon (A), transverse colon (T), descending colon (D), sigmoid colon (S), rectosigmoid (RS), upper rectum (Ra), or lower rectum (Rb). 3. Diagnosed by contrast-enhanced chest/abdominal/pelvic CT as unresectable Stage IV or recurrent colorectal cancer. If contrast-enhanced CT is not possible due to allergy, renal dysfunction, bronchial asthma, or patient refusal, plain CT or MRI is acceptable. 4. History of first-line systemic therapy for advanced or recurrent colorectal cancer (second-line setting). Patients who relapse or progress during perioperative chemotherapy or within 6 months after the last dose are considered refractory to that chemotherapy, and it is regarded as first-line therapy. 5. Patients for whom administration of oxaliplatin and irinotecan is considered difficult in second-line pharmacotherapy for colorectal cancer eligible for this study, based on age and/or comorbidities. Examples include: Age >= 80 years Severe adverse events (Grade >= 3) during prior treatment, making standard chemotherapy difficult to administer Presence of comorbidities or other conditions that make administration of oxaliplatin and irinotecan difficult 6. RAS or BRAF V600E mutation status (wild-type, mutant, or unassessable) and MSI or MMR status must be confirmed. If tested multiple times, the first result is adopted. 7. Age >= 18 years at registration. 8. ECOG Performance Status 0 to 2 (limited to 0 to 1 in patients >= 75 years). 9. Presence of measurable lesions (definition in Section 11.1.2). 10. Ability to take oral medication and consume a normal diet. 11. Laboratory values obtained within 7 days before registration (same weekday acceptable) Neutrophils >= 1000 /mm3 Hemoglobin >= 8.0 g/dL (no transfusion within 14 days before test) Platelets >= 75000 /mm3 Total bilirubin <= 1.5 mg/dL AST <= 100 U/L (<= 200 U/L in patients with liver metastasis) ALT <= 100 U/L (<= 200 U/L in patients with liver metastasis) Serum creatinine <= 1.5 mg/dL Urine protein <= 1+ by dipstick OR urine protein/creatinine ratio <= 2.0 12. Availability of required TR study samples (tumor tissue or NGS data and blood samples; see Section 2.7). 13. Written informed consent obtained from the patient.
Exclude criteria	1.Eligible for second-line therapy with oxaliplatin or irinotecan. 2.Prior treatment with fruquintinib. 3.Active double or multiple cancers that affect prognosis (synchronous or metachronous within 2 years). 4.Active infection requiring systemic treatment. 5.Fever of 38.0 degrees C or higher at registration. 6.Pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; or male patients whose partners may become pregnant. 7.Psychiatric disorders that interfere with participation in the study. 8.Continuous systemic steroid therapy or immunosuppressive therapy. 9.Uncontrolled hypertension. 10.Angina pectoris with onset or exacerbation within 3 weeks before registration. 11.Uncontrolled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 12.Positive hepatitis C virus antibody. 13.Positive human immunodeficiency virus antibody (testing is not mandatory). 14.Active or persistent bleeding. 15.Brain metastasis, unless excluded by contrast-enhanced CT or MRI in patients with central nervous system symptoms. 16.Ascites, pleural effusion, or pericardial effusion requiring drainage within 4 weeks before registration. 17.Surgery requiring general anesthesia within 4 weeks before registration, except for stoma creation performed 2 weeks or more before registration. 18.Chronic lung disease requiring oxygen therapy. 19.Unresolved treatment-related adverse events of Grade 2 or higher according to CTCAE version 5.0, except for anemia, alopecia, hyperpigmentation, hypertension, acneiform rash or dry skin, hypomagnesemia, hypokalemia, and hypocalcemia. 20.Unstable thromboembolic disease, except for catheter-related stable cases or deep vein thrombosis adequately controlled with direct oral anticoagulants or other anticoagulants.