Radiofrequency Ablation Plus Systematic Neoadjuvant Therapy for Recurrent Hepatocellular Carcinoma (RANT Study)

Sponsor
Southwest Hospital, China
Study ID
NCT05277675
Status
Unknown

Conditions

  • Hepatocellular Carcinoma Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab/Sintilimab+Lenvatinib/Bevacizumab — DRUG
    Immune checkpoint inhibitor (tislelizumab/sintilimab) combined with anti-angiogenic drugs (lenvatinib/bevacizumab) used as neoadjuvant therapy
  • RFA — PROCEDURE
    RFA will be performed in a percutaneous way guided contrast enhanced ultrasound.

Study Details

1. To compare systemic neoadjuvant therapy (combination of immune checkpoint inhibitors and anti-angiogenic drugs (short for "targeted-immune therapy") combined with radiofrequency ablation (RFA) and RFA alone in the treatment of recurrent hepatocellular carcinoma(HCC) in 1-year recurrence-free survival (RFS) and overall survival (OS) 2. To evaluate the clinical value of systemic neoadjuvant therapy (i.e. immune checkpoint inhibitors and targeted therapy) combined with RFA in the treatment of recurrent HCC, as well as the safety and efficacy of this strategy.

Key Dates

First listed
Mar 14, 2022
Start date
Nov 1, 2021
Status verified
Mar 2022
Primary completion
Nov 1, 2022
Completion
Oct 30, 2023

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant therapy+ RFA
    After confirmation of HCC recurrence by imaging exam, subjects will receive neoadjuvant therapy (immune checkpoint inhibitors + targeted therapy) and then RFA
  • Active Comparator: RFA alone
    After confirmation of HCC recurrence by imaging exam, subjects will receive RFA treatment only.

Primary Outcome Measure

1-year recurrence-free survival [ Time Frame: 1 year after treatment ]

Central Contacts

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