This study is a single-center, exploratory clinical trial. Eligible patients with liver cancer, after signing the informed consent form, will be screened and enrolled. They will receive a 3-cycle conversion treatment with Envafolimab combined with Suvemcitug and HAIC. During the treatment process, clinical tumor imaging assessment will be conducted using RECIST V1.1. Imaging evaluations will be performed before treatment and at the end of the 3rd cycle of treatment (±3 days). Subsequently, an MDT assessment will be conducted to determine if the surgical resection criteria are met. If the criteria are met, a radical surgery will be performed based on the subject's wishes and postoperative treatment will be provided. If the criteria are not met, the study will be decided to continue with the original treatment plan or another treatment plan. CTCAE 5.0 will be used for safety assessment. Adverse events will be recorded throughout the study period until 30 days after the end of treatment (for severe adverse events or adverse events related to Envovalimab, the recording period will be extended to 90 days after the end of treatment). To ensure study safety, 3 patients will be enrolled as a safety introduction cohort first, and a 3-cycle conversion treatment with Suvemcitug combined with Envafolimab and HAIC will be used. If a DLT occurs, 3 more patients will be enrolled. If the overall DLT does not exceed 1/3, the original treatment plan will be maintained for the study. If the overall DLT is greater than 1/3, the drug related to the DLT will be re-evaluated and the dose will be adjusted.
Age range
18 Years – 75 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Surgical conversion rate
Timeframe: The conversion rate for the first to third cycles of medication (each cycle lasting 21 days)