Tests AK104 with lenvatinib in liver cancer after first-line treatment
Compares AK104 plus lenvatinib with lenvatinib alone in adults with advanced liver cancer.
Plain-language title generated from the registry record
Registry title: A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC
Key facts
- Where
- Koszalin and Warsaw, PolandSee the 2 sites
- Phase
- Phase 2
Where in Poland
- Szpital Wojewodzki im. Mikolaja Kopernika w KoszalinieKoszalin, PolandNot yet recruiting
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Akeso
- Trial code
- NCT06984718EU 2025-524591-30-00
- Record updated
- 22 May 2025
- Original description
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.Read full original descriptionShow less
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
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.
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: 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 bleeding event due to esophageal and/or gastric varices within 6 months prior to the first dose of study treatment; Has a known history of, or any evidence of CNS metastases; History of liver transplantation; History of hepatic encephalopathy; Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC; Tumor thrombus invasion of superior mesenteric vein; Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites.