Icaritin Soft Capsules+TACE+Immunotherapy+Targeted Therapy Versus TACE+Immunotherapy+Targeted Therapy for Unresectable Hepatocellular Carcinoma

Launched by ZHIYONG HUANG · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with advanced liver cancer, known as unresectable hepatocellular carcinoma (HCC), which cannot be surgically removed. The study is comparing the effects of a combination treatment that includes Icaritin soft capsules, a natural compound thought to enhance the effectiveness of existing therapies, alongside transcatheter arterial chemoembolization (TACE), immunotherapy, and targeted therapy. The goal is to see if this combination can improve treatment outcomes and help patients live longer.

To participate in this trial, patients need to be between 18 and 75 years old, have a confirmed diagnosis of HCC, and have not undergone previous systemic treatments. They should also have measurable liver lesions suitable for TACE treatment and meet certain health criteria, such as good liver function. Participants can expect to receive regular treatment and monitoring, and they will need to agree to follow certain guidelines, including using effective birth control if applicable. This trial is not yet recruiting, so more information will be available as it progresses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 1) Age range: 18-75 years old; 2) Patients diagnosed with hepatocellular carcinoma or cirrhosis through histology/cytology meet the clinical diagnostic criteria for hepatocellular carcinoma by the American Association for the Study of the Liver (AASLD). The clinical diagnostic criteria refer to the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)"; 3) Advanced primary liver cancer patients who have not received systematic treatment in the past or advanced liver cancer patients who have not received systematic treatment and have relapsed after radical resection; 4) Diseases are not suitable for radical surgery, transplantation, or ablation, but diseases are suitable for TACE treatment 5) At least one measurable lesion. Single tumor, diameter ≤ 10.0cm or multiple tumors; Number ≤ 10; The tumor burden of the lesion is less than 50%; 6) ECOG score 0-1 points; 7) Child Pugh liver function grade A; 8) Expected lifespan ≥ 3 months; 9) Blood, liver, and kidney function meet the following criteria:
• • 1. Absolute neutrophil count ≥ 1.0 × 109/L;
• • 2. Platelet count ≥ 75 × 109/L;
• • 3. Hemoglobin concentration ≥ 90g/L;
• • 4. Serum albumin concentration ≥ 28g/L;
• • 5. Serum total bilirubin ≤ 3 x upper limit of normal (ULN);
• • 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN;
• • 7. The prothrombin time extension shall not exceed ULN6s;
• • 8. Creatinine\<1.5 × ULN or creatinine clearance rate (CrCl)\>60 mL/min (Cockcroft Gault formula); 10) If the patient is HBsAg positive, HBV-DNA should be below 2000 IU/ml (10000 copies/ml) during treatment; 11) Women with fertility must undergo a negative pregnancy test; 12) Acceptable contraceptive methods must be used during the research period; 13) Can understand and be willing to sign a written informed consent form; 14) Capable of swallowing and absorbing oral pills; 15) Use up to 3 types of antihypertensive drugs to fully control blood pressure, defined as systolic/diastolic blood pressure ≤ 150/90 mmHg during screening, and no change in antihypertensive treatment within the first week/week prior to the first cycle.
• Exclusion Criteria:
• • 1) Diffuse infiltrative lesions of the liver and brain metastases; 2) There are TACE contraindications, such as portosystemic shunt, hepatic blood flow and obvious atherosclerosis; 3) Individuals allergic to intravenous contrast agents; 4) Local treatment has been performed on existing lesions (e.g.: TACE、 Melting, particles TARE、 Hepatic artery infusion chemotherapy or radiotherapy); 5) The subject is unable to undergo enhanced liver CT or MRI scans; 6) Previous history of liver transplantation or current candidate for liver transplantation; 7) Pregnant, lactating women or participants planning to undergo contraceptive procedures within 2 years; 8) Patients with combined HIV and syphilis infections; 9) Patients with other concurrent malignant tumors or other malignant tumors within the first 5 years of enrollment; 10) Patients with severe functional impairments of the heart, kidneys, and other organs; 11) Severe clinical active infection\>Level 2 (NCI-CTC version 5.0); 12) Mental illness patients who may affect the informed consent process; The patient is unable to take oral medication; The patient participated in clinical trials of other drugs within 12 months prior to enrollment.
• • 13) Patients who have experienced esophageal or gastric variceal rupture bleeding within the past 3 months, or have unconfirmed severe varices and are at high risk; 14) Has bleeding or thrombotic disease or is undergoing thrombolytic therapy; 15) Clinical significant hemoptysis or tumor bleeding for any reason within 2 weeks prior to the first administration of the study intervention; 16) Major cardiovascular damage within the 12 months prior to the first administration of the investigational drug, such as a history of NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction or cerebrovascular accident stroke, or arrhythmia related to hemodynamic instability; 17) There is clinically significant ascites during physical examination, which cannot be controlled with medication; 18) History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barr é syndrome, or multiple sclerosis 19) Idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, or history of idiopathic pneumonia, or evidence of active pneumonia on chest CT scan during screening 20) Known to be allergic to any component of the investigational drug formulation; 21) Other situations where the researcher deems it inappropriate to participate in the study.