Status:
ACTIVE_NOT_RECRUITING
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
Lead Sponsor:
Akeso
Conditions:
Unresectable, Non-metastatic Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05319431
Start Date
June 28 2022
End Date
June 30 2025
Last Update
March 12 2025
Active Locations (5)
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1
The First Hospital of Beijing University
Beijing, Beijing Municipality, China, 100034
2
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
3
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
4
Hunan Cancer Hospital
Changsha, Hunan, China, 410013