RecruitingPhase 2NCT06018714

Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study

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

Sponsor

Sun Yat-sen University

Enrollment

64 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic

Summary

The overall 5-year survival rate for patients with colorectal liver metastases (CRLM) is still less than 20%. Surgery-based local treatment can achieve no evidence of disease (NED) in CRLM patients, but over 60% of patients experience recurrence even after achieving NED. Even with adjuvant therapy for the 6-month perioperative period after achieving NED, the recurrence rate remains high. Fruquintinib is a selective anti-angiogenic inhibitor that may help reduce tumor recurrence and prolong the time to recurrence and metastasis. The Chinese Society of Clinical Oncology (CSCO) guidelines have recommended fruquintinib as a third-line therapy for colorectal cancer. This study aims to evaluate the effectiveness and safety of fruquintinib as a maintenance therapy for patients with advanced colorectal cancer (CRC) who have achieved no evidence of disease (NED) after completing adjuvant chemotherapy.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether fruquintinib (a targeted anti-cancer drug) can prevent colorectal cancer from returning in the liver after patients have achieved no visible disease following surgery, ablation, or radiation for liver metastases. **You may be eligible if...** - You are between 18 and 75 with confirmed colorectal cancer that spread to the liver - Your liver metastases were fully treated (by surgery, ablation, or targeted radiation) with no remaining visible cancer - You completed first-line chemotherapy before your local liver treatment and were responding or stable - You completed adjuvant chemotherapy after achieving no visible disease, with the last dose within 2 months of enrollment **You may NOT be eligible if...** - Your cancer has progressed before or after enrollment - You have intestinal blockage or other serious conditions (HIV, active hepatitis B or C) - You are pregnant or breastfeeding without adequate contraception - You have uncontrolled high blood pressure, serious heart problems, or poor kidney function - You have a history of organ transplant or another cancer in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFruquintinib

Drug: Maintenance treatment regimen: Fruquintinib 5 mg, qd, po, with three weeks of continuous treatment followed by one week of drug discontinuation. Each treatment cycle lasts four weeks. The treatment will be continued for six months, or until tumor recurrence, metastasis, or intolerable drug toxicities occur within six months. Adverse drug reactions that occur during the trial will be graded according to the NCI CTCAE version 5.0 and dose adjustments will be made according to the corresponding rules.