Not yet recruiting NCT06196775
A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK104+AK112.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single-arm, Single-center, Phase II Clinical Trial of Cadonilimab (Anti PD-1/CTLA-4) Combined With AK112 (Anti VEGF/PD-1) as Second-line Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
Overview
To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.
Interventions
- Biological 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dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.
Primary outcome measures
- Progression-Free-Survival [Time frame: From the first drug administration up to two years]
Secondary outcome measures (4)
- Objective Response Rate [Time frame: From the first drug administration up to two years]
- Disease control Rate [Time frame: From the first drug administration up to two years]
- Overall survival [Time frame: From the first drug administration up to two years]
- Incidence of Adverse Events [Time frame: From the first drug administration to within 90 days for the last dose]
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 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Harbin Medical University Hospital — Harbin
Identifiers
NCT: NCT06196775 · AK104-IIT-042