Clinical trial NCT04542837: The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
Official title: A Phase II Study Evaluating the Safety and Efficacy of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HCC
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 55
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: This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology；
* Barcelona Clinic Liver Cancer (BCLC) Stage B or C；
* Age ≥18 years or ≤75 years for both genders；
* ECOG performance status: 0-1；
* Child Pugh score≤7；
* LVEF≥50% or above LLN of the research institution；
* Enough organ function；
* Has at least one measurable lesion based on RECIST 1.1；
* Life expectancy ≥3 months；
* Patients must be able to understand and willing to sign a written informed consent document；

Exclusion Criteria:

* Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc;
* Tumor thrombus invasion at the main portal vein (Vp4), inferior vena cava or heart involvement;
* Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);
* Subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration;
* Subjects who need corticosteroids or immunosuppressive agents for systemic therapy;
* Any previous or current active autoimmune disease or history of autoimmune disease;
* History of hepatic encephalopathy or liver transplantation;
* History of interstitial lung disease or non-infectious pneumonia;
* History of allergic reactions to related drugs;
* Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;
* With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable;
* Subjects with clinically significant gastrointestinal bleeding or thrombosis or embolic events within 6 months;
* Untreated hepatitis infection: HBV DNA\>2000IU/ml or10000 copies/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive;
* Evidence of active pulmonary tuberculosis (TB);
* Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
* Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage;

Primary outcomes:
measure: ORR
timeFrame: 1 year after the last patient's enrollment
Secondary outcomes:
measure: ORR
timeFrame: 1 year after the last patient's enrollment
measure: DCR
timeFrame: 1 year after the last patient's enrollment
measure: DOR
timeFrame: 1 year after the last patient's enrollment
measure: TTR
timeFrame: 1 year after the last patient's enrollment
measure: PFS
timeFrame: 1 year after the last patient's enrollment
measure: OS-12m rate
timeFrame: 1 year after the last patient's enrollment
measure: OS
timeFrame: 2 year after the last patient's enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
Study officials:
References: