An Open Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AK104 Plus Lenvatinib and TACE in the Treatment of Unresectable, Non-metastatic Hepatocellular Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- TACE
- Conditions
- Unresectable, Non-metastatic Hepatocellular Carcinoma
- Sponsor
- Akeso
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed written informed consent form voluntarily.
- •Histologically or cytologically documented hepatocellular carcinoma.
- •CNLC IIa IIb or IIIa
- •The main portal vein was not completely obstructed,
- •Child-Pugh A or B
- •At least one measurable lesion according to RECIST criteria
- •ECOG PS 0-1
- •Adequate organ function
- •Estimated life expectancy of ≥3 months
- •For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent
Exclusion Criteria
- •Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc
- •For HCC lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were more than 10 lesions
- •The main portal vein and the left and right primary branches were clogged with cancer thrombus
- •History of hepatic encephalopathy or liver transplantation
- •Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
- •Occurred arteriovenous thromboembolic events within 6 months before the first administration.
- •Inadequately controlled hypertension.
- •Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome.
- •Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
- •Severe infections.
Arms & Interventions
AK104+Lenvatinib+TACE
Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight\<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study.
Intervention: TACE
AK104+Lenvatinib+TACE
Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight\<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study.
Intervention: AK104
AK104+Lenvatinib+TACE
Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight\<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study.
Intervention: Lenvatinib
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Up to 2 years
Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first.
Secondary Outcomes
- Objective response rate (ORR(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Duration of response (DoR)(Up to 2 years)
- Number of participants with adverse events (AEs)(the time of informed consent signed through 90 days after the last dose)