AK104: Subjects will receive AK104 until disease progression or for a maximum of 24 months
Lenvatinib: Subjects will receive lenvatinib until disease progression or for a maximum of 24 months
TACE: On demand TACE
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)
Progression-free survival (PFS) — Up to 2 years Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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