Using Regorafenib to Maintain Treatment in Patients with Metastatic Colorectal Cancer
Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC) Without Imaging Progress Three Months After Second-Line Treatment
This study is testing if the drug regorafenib can help people with metastatic colorectal cancer stay stable longer after their second-line treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05818267 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of regorafenib as a maintenance therapy for patients with metastatic colorectal cancer (mCRC) who have achieved stable disease or partial response after second-line treatment. Patients will receive regorafenib to assess its impact on prolonging progression-free survival, overall survival, and quality of life compared to standard therapies. The study aims to determine if advancing regorafenib can improve patient outcomes following initial treatment. Participants must meet specific eligibility criteria, including having measurable metastatic disease and maintaining stable disease for at least three months.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed metastatic colorectal cancer who have achieved stable disease after second-line therapy.
Not a fit: Patients with concurrent primary tumors, certain genetic markers, or significant organ insufficiencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with metastatic colorectal cancer.
How similar studies have performed: Other studies have shown promising results with regorafenib in treating metastatic colorectal cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histologically or cytologically confirmed metastatic colorectal cancer who have measurable metastatic disease according to the Resolute Efficacy Criteria for Solid Tumors (RECIST) version 1.1. * Received standard second-line therapy, achieved stable disease(SD) and above by recist1.1 tumor assessment and maintained for 3 months. * Eastern Oncology Collaborative Group(ECOG) physical status of 0 or 1 at trial entry and life expectancy ≥ 3 months. * No bone marrow suppression and normal heart, lung, liver and kidney function. * Voluntary participation in research. Exclusion Criteria: * Concurrent primary tumors of other types. * MSI-H/dMMR type mCRC patients. * Heart, liver, kidney, bone marrow insufficiency or mental abnormalities. * Intolerant to treatment methods * Concurrent participants in other clinical trials. * Pregnant or lactating women. * Patients deemed unsuitable for study participation by the remaining investigators.
Where this trial is running
Shanghai, Shanghai
- Department of Colorectal Surgery in Changhai Hospital — Shanghai, Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.