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

Phase 2

Not yet recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT06196775
• Lead Sponsor: Harbin Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Last Update Submitted: 2023-12-25
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Study Start: 2024-01-31
• Primary Completion: 2026-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Harbin Medical University Hospital; 🇨🇳 Harbin, China