Clinical trial NCT03097848: Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma
Official title: Efficacy and Safety of Combination of Sorafenib as Preoperative Adjuvant and Latter Radiofrequency Ablation in the Treatment Of Recurrent Hepatocellular Carcinoma: A Prospective Multicenter Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HCC
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
Collaborators: name: Chengdu PLA General Hospital
name: Sichuan Provincial People's Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Hunan Cancer Hospital
name: Cancer Hospital of Guangxi Medical University
name: The First People's Hospital of Yunnan
name: Yunnan Cancer Hospital
name: Xiangya Hospital of Central South University
name: Xinqiao Hospital of Chongqing
name: The Second Affiliated Hospital of Chongqing Medical University
name: Henan Cancer Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: First Affiliated Hospital of Guangxi Medical University
First posted: 2017-03-31
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease free survival
timeFrame: 1 year
Secondary outcomes:
measure: Time To Recurrence
timeFrame: 3 year
measure: Overall Survival
timeFrame: 3 year
measure: postoperative complications
timeFrame: 6 months
measure: Health economics index
timeFrame: 3 years
measure: mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
References: