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Trial Title:
A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma
NCT ID:
NCT06196775
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
cadonilimab (anti PD-1/CTLA-4 bispecific antibody)
AK112 ( anti VEGF/PD-1 bispecific antibody)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
AK104+AK112
Description:
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plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.
Arm group label:
AK104+AK112
Summary:
To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line
therapy in patients with advanced hepatocellular carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histopathologically confirmed HCC
- 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 timeā„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:
- Severe complications due to primary liver disease
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin Medical University Hospital
Address:
City:
Harbin
Country:
China
Start date:
January 31, 2024
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Harbin Medical University
Agency class:
Other
Source:
Harbin Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06196775
