Unresectable, Non-metastatic Hepatocellular Carcinoma
Conditions
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
Interventions
BIOLOGICALAK104
Subjects will receive AK104 until disease progression or for a maximum of 24 months
DRUGLenvatinib
Subjects will receive lenvatinib until disease progression or for a maximum of 24 months
PROCEDURETACE
On demand TACE
Sponsors
Akeso
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed