hepatocellular carcinoma
Conditions
Interventions
Test group:Target vessel embolisation using temperature-sensitive nanogel embolic agents in TACE therapy
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old (including boundary), gender is not limited; 2. Primary hepatocellular carcinoma confirmed by imaging examination, such as ultrasonography, dynamic enhanced CT or MRI; 3. Patients with stage Ib-IIIa and some stage IIIb hepatocellular carcinoma requiring transarterial chemoembolisation (TACE) (refer to the Guidelines for the Diagnosis and Treatment of Primary Hepatocellular Carcinoma (2022 Edition)). 4. Liver function status Child-Pugh class A or B, Eastern Cooperative Oncology Group (ECOG) score: 0-2; 5. Patient has at least 1 measurable tumour lesion (maximum diameter of target lesion <= 10 cm) that has not been treated with embolisation; 6. Understanding and voluntarily signing the informed consent form, and agreeing to participate in all examinations, treatments and visits according to the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with previous embolisation of the target lesion or first TACE of the target lesion after enrolment requiring combined ablation/local radiotherapy; 2. Diffuse or distant extensive metastasis of liver tumour with expected survival 176.8 µmol/L or 2 mg/dl, or blood creatinine clearance <30 ml/min); 6. The main portal vein trunk is completely embolised by cancerous thrombus/thrombus with little collateral vessel formation; 7. Patients with cachexia or multiple organ failure; 8. Presence of extrahepatic spread, or tumour occupying =70% of the total liver volume; 9. Combination of active hepatitis or severe infections that cannot be treated with TACE at the same time; 10. Patients with significant reduction of blood leukocytes and haematopoiesis (leukocytes <3.0×10^9/L, haematopoiesis <50×10^9/L) that cannot be corrected (except for those with hyper-splenism and chemotherapeutic myelosuppression); 11. Presence of other primary tumours; 12. Pregnant or lactating women; 13. Those who are allergic to contrast media or allergic or contraindicated to other drugs/materials involved in this study; 14. Patients who have participated in clinical trials of other drugs or devices during the same period; 15. Patients who, in the opinion of the investigator, are unfit to participate in this trial for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Embolization success rate;Objective response rate;Score of Child-Pugh and ECOG;Device performance evaluation; | — |
Countries
China
Contacts
Public ContactHuang ming
Yunnan Cancer Hospital
Outcome results
None listed