Hepatocellular Carcinoma
Conditions
Keywords
cadonilimab (anti PD-1/CTLA-4 bispecific antibody), AK112 ( anti VEGF/PD-1 bispecific antibody)
Brief summary
To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.
Interventions
BIOLOGICALAK104+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dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.
Sponsors
Harbin Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival | From the first drug administration up to two years | Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | From the first drug administration up to two years | Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1. |
| Disease control Rate | From the first drug administration up to two years | Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1. |
| Overall survival | From the first drug administration up to two years | Defined as the time between the first dose to death due to any causes. |
| Incidence of Adverse Events | From the first drug administration to within 90 days for the last dose | Use NCI-CTCAE version 5.0 for classification and grading. |
Countries
China
Contacts
Primary ContactYanqiao Zhang, PhD.
Backup ContactGuangyu Wang, PhD.
Outcome results
None listed