A Prospective Study of Cadonilimab in Hepatocellular Carcinoma After Radical Surgery with High Risk of Recurrence

Guangxi Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Cadonilimab (AK104)

Study type: Interventional

Funder types: Other

Identifiers

NCT06851104

PREVENT-3

Details and patient eligibility

About

This study aims to compare the safety and tolerability of cadonilimab applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrent factors.

Full description

Hepatectomy and local ablation are the main curative treatment methods for hepatocellular carcinoma, but the 5-year recurrence rate after surgery is as high as 70%, which is the main bottleneck problem affecting the long-term prognosis of patients. This study aims to investigate the safety and tolerability of cadonilimab (PD-1/cytotoxic T lymphocyte antigen-4 (CTLA-4) bispecific antibody) applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrence factors.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Sign a written informed consent before the implementation of any trial-related procedures.
• Male or female, aged ≥18 years and ≤70 years.
• ECOG PS score is 0 - 1 point.
• Subjects diagnosed with hepatocellular carcinoma by imaging criteria and/or pathology and who have received curative resection.
• The definition of curative resection complies with the definition of curativeness in the 2024 edition of the Chinese Guidelines for Primary Liver Cancer (CNLC).
• The postoperative recurrence risk stratification conforms to the high - risk group in the ERASL - pre or ERASL - post formula.
• No prior systemic antitumor treatment for hepatocellular carcinoma has been received.
• Child - Pugh liver function score of grade A or B7.
• Expected survival time > 6 months.

Exclusion criteria

• Previously diagnosed by histology/cytology, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
• Subjects with other malignant tumors within 5 years before enrollment, except for HCC. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.
• History of hepatic encephalopathy or liver transplantation.
• Portal vein trunk or mesenteric superior vein, inferior vena cava tumor thrombus.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Treatment arm

Experimental group

Description:

Patients with hepatocellular carcinoma after curative hepatectomy would receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months.

Treatment:

Drug: Cadonilimab (AK104)