A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC (NCT05319431) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
China60 participantsStarted 2022-06-28
Plain-language summary
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
* Enr…