Study design
ascites, HCC, encephalopathy
ASCITES, SECONDARY, METASTASES, ENCEPHALOPATHY
Our previous study showed a 1‐year RFS rate of 36.1% in patients with recurrent HCC who underwent local ablation. Assuming that the 1‐year RFS rate increases to 55.0% after combined anti‐PD‐1 therapy in patients with recurrent HCC, we calculated that 40 participants would be required, with 20 participants in each treatment arm, using a two‐sided type I error of 0.05 and a power of 80%.The ethics committee has approved and registered this study with the Chinese Clinical Trials Registry (ChiCTR1900027807). This study is a prospective controlled trial, with RFS as the primary endpoint and safety as the secondary endpoint. Some patients choose to undergo regular check‐ups after RFA instead of opting for combined anti‐PD‐1 therapy due to financial constraints or personal reasons. As a result, this study is a non‐randomized concurrent controlled trial. Upon obtaining informed consent, the investigators divided the patients into a control group and an experimental group based on their individual preferences.The inclusion criteria for this study are as follows: (1) Male or female participants aged 18 years or older. (2) Patients with a confirmed diagnosis of HCC who have experienced relapse within 6 months after RFA treatment or have undergone more than 2 RFA treatments. (3) Recurrent lesions that are suitable for RFA treatment. (4) The patient has one or more observable lesions in the liver, each ≤3 cm in size. (5) The patient has no extrahepatic metastases and no invasion of the portal vein or hepatic vein. (6) The patient has not received any other antitumor therapy, including radiotherapy, TACE, and targeted drugs, prior to this treatment. (7) Child‐Pugh grade A or B, with no current encephalopathy or ascites (small amount). (8) Left ventricular ejection fraction is ≥50%. (9) ECOG physical status is 0–1. (10) Baseline period laboratory tests (repeat laboratory tests are permitted during screening to assess subject eligibility, and before initiating the study treatment, the laboratory findings must conform to the protocol‐specific boundaries), namely, an absolute neutrophil count greater than 1.5 × 10