Suspended
A Phase II Study of AK112 (PD-1/VEGF Bispecific) in Patients With Unresectable Hepatocellular Carcinoma (HCC)
What is being tested
AK112
Drug
Who is being recruted
Adenocarcinoma+8
+ Carcinoma
+ Digestive System Diseases
From 18 to 75 Years
+23 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: August 2022
Summary
Principal SponsorAkeso
Study ContactChengna Wang
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2022
Actual date on which the first participant was enrolled.Phase II open label, multicenter study to evaluate the efficacy and safety of AK112 (PD-1/VEGF Bispecific) in patients with unresectable hepatocellular carcinoma (HCC).
Official TitleA Phase II Study of AK112 (PD-1/VEGF Bispecific) in Patients With Unresectable Hepatocellular Carcinoma (HCC)
Principal SponsorAkeso
Study ContactChengna Wang
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial
Criteria
10 inclusion criteria required to participate
Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
18 to 75 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Have a life expectancy of at least 3 months.
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13 exclusion criteria prevent from participating
With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
History of malignancy other than HCC within 5 years, except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Have a history of hepatic encephalopathy or have a history of liver transplantation.
With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSubjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression.
Group II
ExperimentalSubjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers