A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT06196775
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2024-01-31
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AK104+AK112
AK104+AK112
Cadonilimab (AK104): 10mg/kg or 15mg/kg Q6W iv D8 (dose choosing depends on the outcome of the dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.
Interventions
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AK104+AK112
Cadonilimab (AK104): 10mg/kg or 15mg/kg Q6W iv D8 (dose choosing depends on the outcome of the dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.
Eligibility Criteria
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Inclusion Criteria
* Age 18-75 years old
* ECOG PS 0-1
* Child Pugh A-B7
* Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
* At least one measurable lesion (RECIST 1.1)
* Enough organ and bone marrow function
* Expected survival time≥12 weeks
* Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol
Exclusion Criteria
* No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
* Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
* Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
* Autoimmune immune disease
* History of HIV
* Prognent women
* The presence of any serious or uncontrolled systemic disease
* Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
18 Years
75 Years
ALL
No
Sponsors
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Harbin Medical University
OTHER
Responsible Party
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Yanqiao Zhang
Director
Locations
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Harbin Medical University Hospital
Harbin, , China
Countries
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Central Contacts
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Other Identifiers
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AK104-IIT-042
Identifier Type: -
Identifier Source: org_study_id
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