Status:
NOT_YET_RECRUITING
A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC
Lead Sponsor:
Akeso
Conditions:
HCC
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 hepatocell...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06984718
Start Date
June 25 2025
End Date
June 30 2027
Last Update
May 22 2025
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