Trial | NCT03097848  Report issue

Title

Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma
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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Indication/Condition

    HCC

  • Intervention/Treatment

    sorafenib ...

  • Study Participants

    450
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.
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.
Study Started
May 04
2017
Primary Completion
Dec 30
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
May 08
2017

Procedure RFA

for eligible cases, radiofrequency ablation will be given only.

  • Other names: control group

Drug Sorafenib

for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation

  • Other names: experimental group

Sorafenib+RFA group Experimental

for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation

RFA group Active Comparator

for eligible cases, RFA will be given only.

  • Procedure RFA

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.
No Results Posted