A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC

NCT06984718 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-22

No results posted yet for this study

Summary

This is a Phase II, randomized, open-label, global, multi-center study to compare the efficacy and safety of AK104 in combination with lenvatinib versus lenvatinib in patients with advanced hepatocellular carcinoma who have progressed on the first line treatment of atezolizumab and bevacizumab.

Conditions

Interventions

BIOLOGICAL

AK104+lenvatinib

Subjects will receive AK104+lenvatinib until disease progression

DRUG

lenvatinib

Subjects will receive lenvatinib until disease progression

Sponsors & Collaborators

Principal Investigators

  • Richard S. Finn, Ph.D. · Department of Medicine, University of California

  • Jian Zhou, Ph.D. · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2026-11-30
Completion
2027-06-30
FDA Drug
Yes

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Entities

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 NCT06984718 on ClinicalTrials.gov