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
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
-
Subjects will receive lenvatinib until disease progression
Sponsors & Collaborators
- lead INDUSTRY
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
More Related Trials
-
Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
NCT05168163 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)
NCT03713593 ·Status: COMPLETED ·Phase: PHASE3
-
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
NCT05103904 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.
NCT07052253 ·Status: RECRUITING ·Phase: PHASE2
-
Lenvatinib Combined Pembrolizumab in Advanced Hepatobiliary Tumors
NCT03895970 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC
NCT06519721 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
NCT06371157 ·Status: RECRUITING ·Phase: PHASE3
-
Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma
NCT04627012 ·Status: COMPLETED
-
Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab
NCT07047586 ·Status: RECRUITING ·Phase: PHASE2
-
Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma
NCT04642547 ·Status: COMPLETED ·Phase: NA
-
Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC
NCT06361758 ·Status: WITHDRAWN ·Phase: PHASE2
-
Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High-risk Recurrence Factors
NCT05920863 ·Status: RECRUITING ·Phase: PHASE2
-
The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
NCT04542837 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
NCT05489289 ·Status: RECRUITING ·Phase: PHASE3
-
Real-world Study of Lenalidomide After First-line Treatment Lenvatinib With PD-1 in Advanced HCC
NCT07184424 ·Status: COMPLETED ·Phase: NA
-
Pembrolizumab and Lenvatinib in Patients With Advanced HCC Who Are Refractory to Atezolizumab and Bevacizumab/ IO-based Therapy
NCT05101629 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
NCT03006926 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC)
NCT04172571 ·Status: COMPLETED ·Phase: PHASE2
-
Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma
NCT05954897 ·Status: RECRUITING ·Phase: PHASE2
-
Lenvatinib After Progression on Atezolizumab-bevacizumab in Hepatocellular Carcinoma
NCT06138769 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Lenalidomide to Reverse Drug Resistance After First-line Treatment of Advanced HCC
NCT05831969 ·Status: UNKNOWN ·Phase: PHASE2
-
Lenvatinib Combined Toripalimab in Advanced Hepatocellular Carcinoma
NCT04368078 ·Status: UNKNOWN ·Phase: PHASE2
-
Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma
NCT01210495 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC
NCT04791176 ·Status: COMPLETED ·Phase: PHASE2
-
Lenvatinib Plus HAIC of Modified FOLFOX Regime vs Lenvatinib Plus HAIC of ROX Regime in Patients With Advanced HCC
NCT05007587 ·Status: UNKNOWN ·Phase: EARLY_PHASE1