The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

Peking University Cancer Hospital & Institute

Status and phase

Completed

Phase 2

Conditions

HCC

Treatments

Biological: KN046

Drug: Lenvatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT04542837

20200825

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;