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NCT Number: NCT06196775

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Harbin Medical University Hospital

Harbin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AK104+AK112

Biological

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dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guangyu Wang, PhD.

CONTACT

[email protected]

18249038966

Yanqiao Zhang, PhD.

CONTACT

[email protected]

13845120210

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 9, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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