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

December 25, 2023 updated by: Yanqiao Zhang, Harbin Medical University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Harbin, China
        • Harbin Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AK104+AK112
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free-Survival
Time Frame: 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.
From the first drug administration up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 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.
From the first drug administration up to two years
Disease control Rate
Time Frame: 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.
From the first drug administration up to two years
Overall survival
Time Frame: From the first drug administration up to two years
Defined as the time between the first dose to death due to any causes.
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
Use NCI-CTCAE version 5.0 for classification and grading.
From the first drug administration to within 90 days for the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

December 25, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 25, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK104-IIT-042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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