A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
- Conditions
- Unresectable, Non-metastatic Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT05319431
- Lead Sponsor
- Akeso
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
- Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
- Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
- Unable to receive an enhanced CT or MRI scan of the liver.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AK104+Lenvatinib+TACE AK104 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. AK104+Lenvatinib+TACE Lenvatinib 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. AK104+Lenvatinib+TACE 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.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 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 Outcome Measures
Name Time Method Objective response rate (ORR Up to 2 years ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Disease control rate (DCR) Up to 2 years The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
Duration of response (DoR) Up to 2 years Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Number of participants with adverse events (AEs) the time of informed consent signed through 90 days after the last dose An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Trial Locations
- Locations (5)
The First Hospital of Beijing University
🇨🇳Beijing, Beijing, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China