Metastatic colorectal cancer
Conditions
Interventions
Group A (control):Modified FOLFOX chemotherapy (5 days 3 weeks) 3 cycles
Group B (treatment):Modified FOLFOX chemotherapy (5 days 3 weeks) for 3 cycles
APDC biological immunotherapy for 2 cycles
4 times in total
Sponsors
The Second Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: MRI is greater than or equal to 1.0cm or 2.0cm measured by general CT or chest X-ray. 3. Age 18-75y, male or female; 4. KPS>=70. The expected survival time is more than 3 months; 5. Without treatment of oxaliplatin-containing program in the past; 6. The liver, kidney, marrow function is almost normal: WBC>=3.5*10^9/L, Hb>=90g/L, PLT>=90*10^9/L; SCr<=1.5, Serum TBIL<=1.5 times of the normal limit, ALT, AST<=2.5 times of the normal limit, ALT/AST<=5 times of the normal limit in patients with liver metastasis; 7. The patients can be obtained a certain number of tumor tissue through surgical treatment or other method; 8. Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Vital organs (heart, liver, kidney) function is serious dysfunction; 2. Metastatic area>50% of liver volume; 3. Patients received organ transplantation; 4. Patients with other malignant tumors or have occurred brain metastasis; 5. Patients with history of autoimmune disease; 6. Patients in pregnancy or breast-feeding period (women of child-bearing age need to check pregnancy test); 7. Patients with acute infection disease or in chronic active stage; 8. Patients with clear history of drug allergy or belong to allergic constitution; 9. Patients received chemotherapy, radiation therapy, immunosuppressive drugs (cyclosporine A, etc.) or other immune treatment in 4 weeks; 10. Patients received other clinical trials in 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective efficienc; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune effectiveness, KPS, CE; | — |
Countries
China
Contacts
Public ContactYajie Wang
Outcome results
None listed