Hepatocellular carcinoma
Conditions
Interventions
Research group:Use of balloon microcatheters during TACE surgery to complete surgery
Control group:Use of microcatheters to inject embolic agents during TACE surgery to complete the operation
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participate and sign the informed consent; 2. Age 18-80 years old, male or female; 3. Patients with confirmed hepatocellular carcinoma who have been diagnosed by histopytology or in accordance with the clinical diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition); 4. The tumor stage was Chinese Clinical Stage of Liver Cancer (CNLC) Stage Ia-IIIb 5. Expected survival =3 months; 6. There is a target lesion with a diameter > 30mm that has not received any treatment; Not more than 100mm 7. Blood, liver and kidney function indexes are resistant to interventional therapy;
Exclusion criteria
Exclusion criteria: Exclusion criteria: Subjects will not be included in the study if they meet any of the following criteria: 1. Patients who had received local treatment other than surgery (including but not limited to radiotherapy, hepatic arterial perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection, etc.) within 1 month before participating in the study were not allowed to be enrolled, and patients who had received TACE treatment > 3 times in the past were not allowed to be enrolled. 2. Received systemic anti-tumor therapy (including but not limited to targeted therapy, immunotherapy, chemotherapy, etc.) before participating in the study; 3. Thrombotic or embolic events occurred within 6 months prior to the start of the study treatment, such as outside the cerebral vessel (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism, etc.); 4. Patients with coagulation dysfunction that cannot be corrected; 5. The main portal vein is completely blocked; 6. Target lesion supplying arteries cannot be treated with TACE or there is a risk of embolization; 7. Known severe hypersensitivity to contrast media or embolization materials; 8. Participate in clinical experiments of other drugs or devices within 3 months; 9. Had a history of intestinal obstruction and/or had clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to the start of study treatment, including incomplete obstruction related to pre-existing disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; 10. Patients with congenital or acquired immune deficiency (such as HIV infection); 11. Received another investigational drug within 28 days prior to initiation of study treatment; 12. According to the investigator's judgment, the patient has other factors that may affect the study results or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, and family or social factors, which will affect the safety of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective relief rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Progression free survival;Duration of relief; | — |
Countries
China
Contacts
Public ContactRong Liu
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed