liver malignant tumor
Conditions
Interventions
trial group:multi-mode tumor ablation (cryoablation combined with radiofrequency ablation)
control group:withradiofrequency ablation
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years to 70 years of either gender; 2. Histologically/cytologically confirmed hepatocellular carcinoma or colorectal cancer with liver metastasis, the primary lesion had underwent radical resection and without local recurrent, extrahepatic metastasis; 3. At least one measurable liver metastasis by RECIST criteria. No more than 5 lesions and smaller than 4.0 cm each; 4. Patients' liver function classified as Child-Pugh A or B, total bilirubin=3.0 mg/dL, serum creatinine=2.5 mg/dL, White blood cell count = 2.0×10^9/L, Platelets = 100×10^9/L; 5. ECOG PS = 2, and life expectancy longer than three months; 6. Prior therapy, e.g., chemotherapy, radiation, is allowed provided that more than one month washout time is given, and recover from the previous treatment: according to the CI-CTC AE version 4.0, all side effects (except for hair loss) degrading to 1 level or lower.
Exclusion criteria
Exclusion criteria: 1. Child-Pugh grade Class C, or tumor invasion into the portal vein; 2. Patient underwent previous cryoablation or other thermal ablation; 3. Patient underwent prior therapy, e.g., chemotherapy, radiation,or other anti-cancer medication no more than 3 weeks; 4. Patients with severe disorders of heart, lung, liver, kidney functioni or rreversible coagulation disorder; 5. Patients combined with other uncontrolled disease, including but not limited to: hypertension or diabetes, active infection, or mental illness or social condition that may affect the subject's compliance; 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local control; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression free survival;Immune state; | — |
Countries
China
Contacts
Public ContactWen-Tao Li
Fudan University Shanghai Cancer Center
Outcome results
None listed