HCC
Conditions
Brief summary
Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.
Detailed description
Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study. Eligible cases will be assigned into the experimental group and the control group. For experiment group, sorafenib tablet will be given for two weeks, and then perform radiofrequency ablation. For the control group, RFA will be performed immediately.
Interventions
PROCEDURERFA
for eligible cases, radiofrequency ablation will be given only.
DRUGSorafenib
for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation
Sponsors
Chengdu PLA General Hospital
Sichuan Provincial People's Hospital
Sichuan Cancer Hospital and Research Institute
Hunan Cancer Hospital
Cancer Hospital of Guangxi Medical University
The First People's Hospital of Yunnan
Yunnan Cancer Hospital
Xiangya Hospital of Central South University
Xinqiao Hospital of Chongqing
The Second Affiliated Hospital of Chongqing Medical University
Henan Cancer Hospital
First Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Guangxi Medical University
Southwest Hospital, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged from 18 to 75 years old * Without gender restriction * With a favorable liver function of Child-Pugh A to B * No contraindications to RFA and anesthesia * Diagnosed with Recurrent HCC * Signed informed consent.
Exclusion criteria
* Cancer thrombosis in major vessels/ extrahepatic metastasis * Uncontrollable ascites or variceal bleeding * Impairment in liver function * Severe disorders in vital organ * Accompanied with other tumors or infectious disease except hepatitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 1 year | 1 year Disease free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time To Recurrence | 3 year | time to tumor recurrence |
| Overall Survival | 3 year | overall survival |
| postoperative complications | 6 months | postoperative complications diagnosed within 6 months |
| Health economics index | 3 years | Health economics index within 3 years |
| mortality | 3 months | mortality occured within 3 months |
Countries
China
Contacts
Primary ContactXiaobin Feng
Outcome results
None listed