Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases

• Status: Not yet recruiting
• Trial end date: 2025-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to explore the therapeutic effect of Quintuple method in the treatment of patients with multiple and refractory liver metastases from colorectal cancer. A randomized single-arm clinical trial was conducted.The intervention group was treated with single SOX chemotherapy, SOX chemotherapy combined with cetuximab targeted therapy, SOX chemotherapy combined with low-dose cetuximab targeted therapy combined with three-drug regimen（Quintuple method）, and the RECIST 1.1 solid tumor evaluation criteria were used to assess the disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liaoning Tumor Hospital & Institute
• Treatments: Cetuximab; Folic Acid; Metronidazole; Oxaliplatin; Tegafur; Vitamin A

Criteria

Inclusion Criteria:

1. Aged 18-80 years at the time of signing the informed consent form;

2. Patients with histologically or cytologically confirmed adenocarcinoma of the colon or rectum (stage IV);

3. Patients with liver metastases found by imaging examination, and liver metastases cannot be radically resected, Or relapse liver metastasis;

4. At least one measurable metastatic lesion as defined by RECIST version 1.1;

5. Genetic test results are Kras/Nras/Braf wild-type or mutation type;

6. ECOG performance status 0-1;

7. Except for the liver, other organs function well;

8. Willingness and ability to comply with scheduled visits, treatment plans,laboratory tests, and other study procedures.

Exclusion Criteria:

1. Patients with non-primary intestinal cancer;

2. Patients whose primary tumor as well as metastases can be radically resected by surgery;

3. One or several serious allergies to each drug required for the trial;

4. Combined with respiratory, circulatory, urinary, hematopoietic and other serious underlying diseases.