Colorectal cancer
Conditions
Interventions
experimental group:mFOLFOXIRI combined with Bevacizumab/Cetuximab
control group:mFOLFOX6 combined with Bevacizumab/Cetuximab
Sponsors
The Third Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with colorectal adenocarcinoma confirmed by histology; 2. Patients with initially unresectable colorectal cancer did not receive treatment for the tumor before; 3. At least one measurable lesion was measured within 4 weeks before registration according to RECIST criteria; 4. Age: 18-70 years old; 5. Activity state score: ECoG 0-1; 6. Life expectancy: at least 12 weeks; 7. Hematological indexes within 7 days after treatment: neutrophil >= 1.5 x 10^9 / L, platelet >= 100 x 10^9 / L, and hemoglobin >= 90 g / L; 8. Liver function: without liver metastasis, AST and alt 50 ml / min; 10. Patients with abnormal sensation who do not affect their function; 11. Patients with informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received chemotherapy, radiotherapy and targeted therapy for primary or metastatic lesions; 2. Microsatellite instability (MSI) or mismatch repair protein function defect (dmmr) was detected in patients with gene detection; 3. Patients with untreated brain metastases or spinal cord compression or primary brain tumors; 4. Patients with uncontrolled central nervous system (CNC) metastasis; Five Patients with serious underlying diseases: heart disease (e.g. cerebrovascular accident (= 1 grade; 8. Patients receiving treatment with another study drug or participating in another study within 4 weeks; 9. Patients with known or suspected allergy to any drug related to this trial; 10. Patients with a history of other malignant tumors within 5 years, except for cervical carcinoma in situ or basal cell carcinoma of skin; 11. Pregnant or lactating women with fertility but not taking adequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;Deepness of Response;Early Tumour Shrinkage Rate ;R0 Resection Rate;The incidence of >=3 grade adverse events;Overall survival (Time Frame: Three years);disease-free survival (Time Frame: 5 years);Overall survival (Time Frame: 5 years); | — |
Countries
China
Contacts
Public ContactJian Dong
The Third Affiliated Hospital of Kunming Medical University
Outcome results
None listed