Clinical trial NCT05319431: A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Unresectable, Non-metastatic Hepatocellular Carcinoma
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.
* 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective response rate (ORR
timeFrame: Up to 2 years
measure: Disease control rate (DCR)
timeFrame: Up to 2 years
measure: Duration of response (DoR)
timeFrame: Up to 2 years
measure: Number of participants with adverse events (AEs)
timeFrame: the time of informed consent signed through 90 days after the last dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: The First Hospital of Beijing University
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Guoliang Shao, MD
role: PRINCIPAL_INVESTIGATOR
References: