Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases

Trial Title: Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases

NCT ID: NCT05774964

Condition: For Patients With Colorectal Cancer Liver Metastases Who Were Not Able to Curative Surgical Resection.Focused on the Treatment Effect With the Quintuple Method

Conditions: Official terms:
Neoplasm Metastasis
Liver Neoplasms
Folic Acid
Vitamin A
Metronidazole
Oxaliplatin
Cetuximab
Tegafur

Conditions: Keywords:
Quintuple method
Colorectal Liver Metastases

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Oxaliplatin
Description: Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area
Arm group label: Chemotherapy alone group
Arm group label: Chemotherapy targeted group
Arm group label: Quintuple method group

Intervention type: Drug
Intervention name: S1
Description: Orally on d2-d15 at 20 mg three times daily
Arm group label: Chemotherapy alone group
Arm group label: Chemotherapy targeted group
Arm group label: Quintuple method group

Other name: Tegafur,Gimeracil and Oteracil Porassium Capsules

Intervention type: Drug
Intervention name: Cetuximab
Description: Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.
Arm group label: Chemotherapy targeted group
Arm group label: Quintuple method group

Intervention type: Drug
Intervention name: Metronidazole
Description: Metronidazole 0.4g/time, qd
Arm group label: Quintuple method group

Intervention type: Drug
Intervention name: Vitamin A
Description: Vitamin A 5,000 units/time, qd
Arm group label: Quintuple method group

Intervention type: Drug
Intervention name: Folic acid
Description: Folic acid 5 mg/time, qd
Arm group label: Quintuple method group

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.

Detailed description: Patients with inoperable colorectal liver metastases were selected for genetic testing and enrolled if Kras/Nras/Braf wild-type was detected. The enrolled patients were randomly divided into three groups, in which patients in the single chemotherapy group were treated with SOX regimen alone for chemotherapy;patients in the chemotherapy targeted group were treated with SOX regimen chemotherapy combined with cetuximab targeted therapy; patients in the Quintuple method group were treated with SOX regimen chemotherapy,cetuximab targeted therapy and folic acid, vitamin A, and metronidazole three-drug regimen. Specific drugs were administered at the following doses: SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and S1 orally on d2-d15 at 20 mg three times daily. Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks, and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area. Metronidazole 0.4 g/time, qd; vitamin A 5,000 units/time, qd; folic acid 5 mg/time, qd. The latter three drugs were continued until the end of all chemotherapy cycles.Tumor markers associated with liver metastases from colorectal cancer,including magnetic resonance imaging and computed tomography, wererepeated every 3 months and disease was assessed using RECIST 1.1 criteria for the evaluation of solid tumors. The primary end point was death, and the secondary end point was disease progression.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Liaoning Tumor Hospital & Institute

Address:
City: Shenyang
Country: China

Start date: March 15, 2023

Completion date: March 15, 2025

Lead sponsor:
Agency: Liaoning Tumor Hospital & Institute
Agency class: Other

Source: Liaoning Tumor Hospital & Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05774964