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

Launched by GUANGXI MEDICAL UNIVERSITY · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called cadonilimab for patients with hepatocellular carcinoma (HCC), which is a type of liver cancer, after they have undergone surgery to remove the tumor. The goal is to see if cadonilimab can help prevent the cancer from coming back in patients who are at high risk for recurrence after their surgery. The trial is not yet recruiting participants, but it will be looking for men and women aged 18 to 70 who have had successful surgery for HCC and meet certain health criteria.

To participate, individuals need to be in good overall health and have a specific score that shows they can carry out daily activities. They should not have received any other cancer treatments before joining the trial. Participants will have regular check-ups to monitor their health and how well the treatment is working. It's important to note that patients with certain liver conditions or other types of cancer may not be eligible for this study. If you or a loved one is interested, it’s a great idea to talk to your doctor to see if this trial might be a good fit.

Gender

ALL

Eligibility criteria

• 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.