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Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE)

NCT07495579 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-03-27

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if lenvatinib or regorafenib can help treat people with advanced liver cancer (hepatocellular carcinoma, HCC) that cannot be removed with surgery after first treatment with immunotherapy-based drug combinations. It will also look at the safety of these treatments.

The main questions this study aims to answer are:

* How long lenvatinib can delay cancer growth in people with good liver function (Child-Pugh)A after dual immunotherapy
* How long people with reduced liver function (Child-Pugh B7-B8) live after treatment with lenvatinib or regorafenib after first-line immunotherapy-based combination treatment
* What side effects people experience during treatment
* How many people have their tumors shrink or disappear

The study has two parts:

In REVIVE-1, participants with Child-Pugh A liver function will receive lenvatinib.

In REVIVE-2, participants with Child-Pugh B7 to B8 liver function will receive either lenvatinib or regorafenib.

Participants will:

* take lenvatinib or regorafenib by mouth
* visit the clinic regularly for physical exams, blood and urine tests, and safety checks
* have computed tomography (CT) scans every 8 weeks to check their cancer
* be followed during and after treatment to assess outcomes and side effects

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Lenvatinib

Lenvatinib is an oral multikinase inhibitor targeting vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), platelet-derived growth factor receptor alpha (PDGFR-α), RET, and KIT. In this study, lenvatinib is administered orally as second-line treatment according to protocol-defined dosing based on liver function and body weight.

DRUG

regorafenib

Regorafenib is an oral multikinase inhibitor targeting angiogenic, stromal, and oncogenic receptor tyrosine kinases including VEGFR, FGFR, PDGFR, KIT, RET, and RAF kinases. In this study, regorafenib is administered orally as second-line treatment according to protocol-defined dosing.

Sponsors & Collaborators

  • Korean Cancer Study Group

    collaborator OTHER

  • Boryung Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Changhoon Yoo · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-04-30
Completion
2028-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07495579 on ClinicalTrials.gov