colorectal cancer liver metastases
Conditions
Interventions
experimental group:FOLFOX +HAI
control group:2 years postoperative recurrence rate
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathology confirmed liver metastasis of colorectal adenocarcinoma; 2. No extrahepatic metastatic lesions, 3. After radical resection for the purpose of radical resection, including surgical treatment after transformation, but the number of baseline liver metastases does not exceed 15; 4. With or without preoperative systemic chemotherapy ± anti-EGFR or anti-angiogenic therapy, and preoperative chemotherapy efficacy evaluation PR / SD (according to RECIST 1.1 standard), 5. Voluntary participation and signing informed consent; 6. Male or female subjects aged 18-70 years; 7. ECOG fitness status score is 0 or 1, 8. The Central Laboratory believes that it has adequate bone marrow, liver and kidney function based on the following Laboratory tests of the sample: Hemoglobin >= 9.0g / dl; Absolute neutrophil count (ANC) > 1,500/mm3; Platelet count >= 80,000/ul; Total bilirubin 50% or PT-INR <2.3; Subjects taking warfarin are closely monitored and evaluated at least once a week until INR is stabilized based on pre-dose measurements (according to local management standards).
Exclusion criteria
Exclusion criteria: 1. Primary tumor needs emergency operation 2. Patients with contraindications to fluorouracil or oxaliplatin 3. Dihydropyrimidine dehydrogenase (DPD) deficiency 4. Liver metastasis in postoperative adjuvant chemotherapy of colorectal cancer or within 6 months after the end of adjuvant chemotherapy 5. Any history of liver interventional therapy (Tai, Hai, TACE). 6. History of cardiovascular disease with severe intolerance: Congestive heart failure with NYHA Level 2; Active CAD (MI occurring in the first 6 months of study is allowed); arrhythmia requiring antiarrhythmic drug treatment (ß - blocker or digoxin allowed); Uncontrolled hypertension. 7. History of HIV infection; 8. History of allogeneic organ transplantation 9. Subjects undergoing renal dialysis 10. Previously or currently suffering from cancer at different primary sites from the cancer assessed in this study, or cancer with different histological manifestations from the cancer assessed in this study, with the following exceptions: carcinoma in situ of cervix, cured basal cell carcinoma, superficial bladder tumor or any cancer cured for more than 3 years before entering the study. 11. Lactating or pregnant women in childbearing period who are not fully contraceptive; 12. Mental or internal factors make patients unable to know and cooperate with the treatment; 13. Participate in other clinical trials at present or within four weeks before selection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence rate and 2-year intrahepatic recurrence rate; | — |
Countries
China
Contacts
Public ContactCai Jianqiang
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed