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
Keywords
Quintuple method, Colorectal Liver Metastases
Brief 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.
Interventions
DRUGOxaliplatin
Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area
DRUGS1
Orally on d2-d15 at 20 mg three times daily
DRUGCetuximab
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.
DRUGMetronidazole
Metronidazole 0.4g/time, qd
DRUGVitamin A
Vitamin A 5,000 units/time, qd
DRUGFolic acid
Folic acid 5 mg/time, qd
Sponsors
Liaoning Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to approximately 2 years | Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 |
| Overall Survival (OS) | Up to approximately 2 years | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time |
| Progression Free Survival (PFS) | Up to approximately 2 years | PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. |
Countries
China
Contacts
Primary ContactZhang Zhongguo, Doctor
Backup ContactYang Xiaoyu, Doctor
Outcome results
None listed