Testing modified fruquintinib for colorectal cancer liver metastases

The Clinical Efficacy of Modified Fruquintinib as Maintenance Treatment for Colorectal Cancer Liver Metastases After NED: Phase II Single-arm Prospective Study

This study is testing a new version of fruquintinib to see if it can help people with advanced colorectal cancer who have had successful treatment and want to prevent their cancer from coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: fruquintinib, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06018714 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of modified fruquintinib as a maintenance therapy for patients with advanced colorectal cancer who have achieved no evidence of disease after completing adjuvant chemotherapy. The focus is on patients with colorectal adenocarcinoma liver metastasis who have undergone curative local treatment. Fruquintinib is a selective anti-angiogenic inhibitor that may help reduce tumor recurrence and prolong the time to recurrence and metastasis. The study aims to provide insights into improving long-term outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with colorectal adenocarcinoma liver metastasis who have undergone curative local treatment and completed adjuvant chemotherapy.

Not a fit: Patients with active disease or those who have not achieved no evidence of disease after treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of colorectal cancer in patients who have achieved no evidence of disease.

How similar studies have performed: Other studies have shown promise with anti-angiogenic therapies in colorectal cancer, suggesting potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. . The pathological diagnosis was colorectal adenocarcinoma liver metastasis；
2. . Age: 18 to 75 years old,allgenders；
3. . Patients who have previously received first-line chemotherapy and have achieved disease control (PR+SD) according to RECIST 1.1;
4. . Patients with liver metastasis of colorectal cancer who have undergone curative local treatment (surgery, ablation, SBRT) and achieved no evidence of disease (NED). Definition of NED: a. After local treatment, no residual signs of primary or metastatic tumors are observed on CT, MRI, PET-CT imaging, or b. No cancer cells are found in biopsies of suspicious lesions；
5. .Completed adjuvant chemotherapy after achieving NED (e.g. 4-8 cycles of CapOX regimen, 6-12 cycles of FOLFOX regimen, or without receiving adjuvant chemotherapy recently) and evaluated as no disease progression. Last chemotherapy within 2 months from enrollment.
6. . The time interval between the last chemotherapy and enrollment does not exceed 2 months;
7. . Performance status (ECOG score) ≤ 2
8. . Hematology: WBC \> 3 × 10\^9 / L; PLT \> 80 × 10\^9 / L; Hb \> 90 g/L;
9. . Liver function: ALT and AST ≤ 2.5 × ULN; bilirubin ≤ 1.5 × ULN;
10. .Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;
11. .Signed informed consent, willingness to undergo treatment according to this protocol, and good compliance with medication.

Exclusion Criteria:

1. .Patients with tumor progression before enrollment following the completion of chemotherapy.
2. .Intestinal obstruction or incomplete intestinal obstruction.
3. .Co-existing with other serious illnesses, including severe electrolyte disorders, bleeding tendencies, etc.
4. .Active or uncontrolled severe infections: a) Known human immunodeficiency virus (HIV) infection. b) Known clinically significant liver disease history, including viral hepatitis \[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (\>1×104 copies/mL or \>2000 IU/mL)\]. c) Known hepatitis C virus (HCV) infection with positive HCV RNA (\>1×103 copies/mL), or other hepatitis, liver cirrhosis.
5. .Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.
6. .Patients with severe brain disorders or mental illnesses (such as depression, mania, obsessive-compulsive disorder, and schizophrenia) that affect the patient's ability to self-report.
7. .Patients with autoimmune diseases, blood system disorders, and a history of organ transplantation, long-term use of steroids, or immunosuppressive agents.
8. .History of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin.
9. .History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation).
10. .Known or suspected allergies to the investigational drug fruquintinib.
11. .Hypertension that cannot be well controlled with antihypertensive medications (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
12. .Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Left ventricular ejection fraction \<50% on echocardiography, poorly controlled arrhythmias.
13. .Urinalysis indicating urine protein ≥2+ and 24-hour urine protein quantification \>1.0g.

Where this trial is running

Guangzhou, Guangdong

• Colorectal Department,SunYat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Junzhong Lin, Doctor

Conditions Colorectal Cancer Metastatic; Colorectal cancer; Fruquintinib