Status:
COMPLETED
A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Alone or in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
Lead Sponsor:
Akeso
Collaborating Sponsors:
Akeso Pharmaceuticals, Inc.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
An open-label multi-center phase II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 alone or in combination with lenvatinib in patients with advanced hepatocell...
Detailed Description
This is a multi-center, multi-cohort, open-label phase 2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 alone or in combinatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04728321
Start Date
January 27 2021
End Date
August 2 2023
Last Update
April 25 2024
Active Locations (1)
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1
The first affilited hospital zhejiang university school of medcine
Hangzhou, Zhejiang, China, 310000