A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06196775
• Other study ID #: AK104-IIT-042
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 31, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: December 2023
• Source: Harbin Medical University
• Contact: Yanqiao Zhang, PhD.
• Phone: 13845120210
• Email: yanqiaozhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Harbin Medical University Hospital	Harbin

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free-Survival	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.	From the first drug administration up to two years
Secondary	Objective Response Rate	Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.	From the first drug administration up to two years
Secondary	Disease control Rate	Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.	From the first drug administration up to two years
Secondary	Overall survival	Defined as the time between the first dose to death due to any causes.	From the first drug administration up to two years
Secondary	Incidence of Adverse Events	Use NCI-CTCAE version 5.0 for classification and grading.	From the first drug administration to within 90 days for the last dose