A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK104+lenvatinib, lenvatinib.
- Who it may be relevant to
- Registry conditions: HCC, Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination With Lenvatinib Versus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab
Overview
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.
Interventions
- Biological AK104+lenvatinib
Subjects will receive AK104+lenvatinib until disease progression - Drug lenvatinib
Subjects will receive lenvatinib until disease progression
Primary outcome measures
- Objective Response Rate (ORR) per RECIST v1.1 by Blinded Independent Central Review (BICR) [Time frame: Up to 24 months]
Secondary outcome measures (5)
- Overall Survival (OS) [Time frame: Up to 24 months]
- Progression-free survival (PFS) assessed by investigator per RECIST v1.1 [Time frame: Up to 24 months]
- Duration of Response (DOR) assessed by investigator per RECIST v1.1 [Time frame: Up to 24 months]
- Time to Response (TTR) assessed by investigator per RECIST v1.1 [Time frame: Up to 24 months]
- Number of participants with adverse event (AE) [Time frame: Up to 24 months]
Eligibility criteria
Inclusion criteria
- Signed the Informed Consent Form (ICF) voluntarily.
- Age ≥18 years at time of signing ICF.
- Histologic or cytologic confirmation of HCC, or clinical diagnosis of HCC as per AASLD criteria.
- BCLC stage B or C, and not suitable for curative surgical or local therapy.
- Participants have progressed on the prior first-line systemic treatment with atezolizumab plus bevacizumab combination treatment.
- At least one measurable lesion according to RECIST v1.1.
- Child-Pugh Class A .
- ECOG performance status of 0 or 1.
- With a life expectancy of ≥3 months.
- Adequate organ and hematologic function.
Exclusion criteria
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Tumor thrombus invasion of superior mesenteric vein.
- Has a known history of, or any evidence of CNS metastases.
- Has received anti-cancer therapy for HCC within 3 weeks prior to the first dose of study treatment.
- Has received systemic anti-cancer therapy other than atezolizumab and bevacizumab.
- Has participated in another clinical study within 4 weeks prior to the first dose.
- History of liver transplantation.
- History of hepatic encephalopathy.
- Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites.
- History of bleeding event due to esophageal and/or gastric varices within 6 months prior to the first dose of study treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06984718 · AK104-225