A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Akeso
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Updated on 5 August 2020
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measurable disease
carcinoma
hepatocellular carcinoma
lenvatinib

Summary

An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.

Description

This is a multi-center, multi-cohort, open-label phase 1b/2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 plus lenvatinib for the treatment of advanced hepatocellular carcinoma.

Details
Condition Adenocarcinoma, Adenocarcinoma, HEPATIC NEOPLASM, liver cancer, HEPATOCELLULAR CARCINOMA, liver cancer
Age 18years - 75years
Treatment Lenvatinib, AK104
Clinical Study IdentifierNCT04444167
SponsorAkeso
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Signed written informed consent form voluntarily
Histologically or cytologically documented hepatocellular carcinoma
BCLC stage C, and non-resectable BCLC stage B
At least one measurable lesion according to RECIST criteria
ECOG of 0 or 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
History of hepatic encephalopathy or liver transplantation
Clinical significance of hydrothorax, ascites or pericardial effusion
Central nervous system metastases and/or carcinomatous meningitis
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
Tumor volume > 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus
Inadequately controlled arterial 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
Clear my responses
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