Primary hepatic carcinoma
Conditions
Interventions
Experimental group:Balloon microcatheter system
Sponsors
Beijing Tsinghua Changgeng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old, age =80 years old, gender unlimited; 2. Diagnosed with liver cancer according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition); 3. Patients with stage Ia to IIIa of Chinese liver cancer stage (CNLC) who need TACE treatment and are not suitable for/refuse surgical resection, liver transplantation, and ablation, and patients with stage IIb liver cancer who are expected to benefit from TACE treatment; 4. The liver function grade is Child-PughA or B grade; 5. ECOG score =2 points; 6. The subject has at least one tumor lesion that is not embolized and can be measured by CT, and no more than 5 lesions can be measured, with the maximum diameter of a single lesion = 6.5cm; 7. Those who agree to participate in the clinical trial and voluntarily sign the informed consent;
Exclusion criteria
Exclusion criteria: 1. Patients who had previously received embolization therapy for the target lesion or required combined ablation/radiotherapy for the first TACE treatment of the target lesion after enrollment; 2. Patients with distant widespread metastases and an expected survival of less than 3 months; 3. Patients with bad fluid or multiple organ failure; 4. Severe liver dysfunction (Child-Pugh grade C), renal dysfunction (serum creatinine > 2 mg/dL or > 176.8 umol/L); 5. Hemoglobin < 9.0g /dL, white blood cells <3.0*109/L, platelets <50* 10%/L (except for hyperplenism and chemotherapy myelosuppression); 6. Patients with coagulation dysfunction that cannot be corrected; 7. Patients with active hepatitis or severe infection who cannot be treated with TACE simultaneously; 8. Portal vein main thousand complete embolization; 9. The target focal blood supply artery cannot be treated with TACE or has the risk of embolization (vascular access endangers normal areas, arteriovenous fistula, portal fistula, thrombosis, etc.); 10. Known severe hypersensitivity to contrast media or embolization materials; 11. Pregnant/lactating women, or those planning a family during the trial; 12.Those who have participated in clinical trials of other drugs or devices within 3 months; 13. Other participants deemed unsuitable for this clinical trial by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Device performance evaluation;Target lesion complete response rate;Target lesion disease control rate;Embolization success rate of target lesion;level of AFP;Score of ECOG;Liver function classification of Child-Pugh;Target arterial pressure;Rate of iodol deposition in target lesions; | — |
Countries
China
Contacts
Public ContactJiahong Dong
Beijing Tsinghua Changgeng Hospital
Outcome results
None listed