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

  • STATUS
    Recruiting
  • End date
    May 21, 2023
  • participants needed
    55
  • sponsor
    Beijing Cancer Hospital
Updated on 24 May 2022

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.

Details
Condition HCC
Treatment Lenvatinib, KN046
Clinical Study IdentifierNCT04542837
SponsorBeijing Cancer Hospital
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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