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

Army Medical University

Status: Unknown

Conditions: HCC

Treatments: Drug: Sorafenib; Procedure: RFA

Study type: Interventional

Funder types: Other

Identifiers

NCT03097848

SWHB 019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Sorafenib+RFA group

Experimental group

Description:

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

Treatment:

Procedure: RFA

Drug: Sorafenib

RFA group

Active Comparator group

Description:

for eligible cases, RFA will be given only.

Treatment:

Procedure: RFA