Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer

Prior treatment

• 1\) Subjects whose target lesions have undergone local treatment (including but not limited to surgery, TACE, radiotherapy, hepatic artery infusion, ablation, etc.), or subjects whose target lesions require ablation/radiotherapy in combination with TACE treatment at the time of enrollment;
• 10\) Patients who are currently using cardiac glycosides;
• 15\) Subjects who have participated in other drug or medical device intervention clinical trials within 30 days before randomization;

Other illness

• 6\) Patients with systemic cachexia or multiple organ failure;
• 7\) Patients with severe infections that cannot be effectively controlled and are not suitable for TACE treatment;
• 12\) Patients who have been diagnosed with other malignant tumors within 2 years before randomization (except for basal cell or squamous cell skin cancer, cervical or breast carcinoma in situ that have been resected radically);

Lab values

• 2\) Subjects whose blood routine test results meet the following criteria: white blood cell count \<3.0×10\^9/L; platelet count \<50×10\^9/L, and this condition cannot be corrected (excluding subjects with hypersplenism or chemotherapy-induced bone marrow suppression);
• 3\) Renal dysfunction: serum creatinine \>176.8 μmol/L or creatinine clearance rate \< 30 ml/min;
• 9\) Known contraindications or allergies to anthracycline chemotherapeutic drugs, calcium chloride injection, contrast media, and embolic materials;

Other

• 4\) Uncorrectable coagulation dysfunction;
• 5\) Uncorrectable hypercalcemia and respiratory acidosis;
• 8\) Complete obstruction of the main portal vein, insufficient collateral compensation of the portal vein, and inability to restore portal venous blood flow to the liver through portal veinoplasty;
• 11\) Patients with target lesions who are at risk of ectopic embolism in the feeding artery (such as vascular access endangering normal areas, uncorrectable arteriovenous fistulas, and portal vein fistulas) or anatomical abnormalities that make them unsuitable for interventional procedures;
• 13\) Patients with diffuse or distant extensive metastasis of tumors, with an expected survival time of less than 90 days;
• 14\) Pregnant/lactating women, or those who have family planning;
• 16\) Other subjects who were considered unsuitable for participation in this clinical trial by the researchers.

• 1\) Aged 18 to 80 (inclusive), of either gender;
• 2\) Subjects who have been diagnosed with hepatocellular carcinoma (pathologically or clinically) according to the diagnostic criteria in the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)" and require TACE treatment;
• 3\) Subjects with stage Ⅱb and Ⅲa liver cancer according to the Chinese Liver Cancer Staging Classification (CNLC), as well as subjects with stage Ⅰa, Ⅰb, and Ⅱa liver cancer who are not suitable/willing for surgical resection, liver transplantation, and ablation therapy;
• 4\) Subjects with at least one untreated intrahepatic tumor lesion (maximum diameter ≤10cm) that meets the mRECIST definition (diameter ≥1cm);
• 5\) The subjects agree to participate in this study and sign the informed consent form.