Disease: Hepatocellular carcinoma (HCC)
Conditions
Interventions
50–80 mL group:The drug-eluting beads were mixed with contrast medium and normal saline to a total volume of 50-80 mL.
The optimal regimen identified in phase I was selected for cohort expansion.:The drug-eluting beads were mixed with contrast medium and normal saline, with the total dilution volume determined accordi
30–50 mL group:The drug-eluting beads were mixed with contrast medium and normal saline to a total volume of 30–50 mL.
80–100 mL group:The drug-eluting beads were mixed with contrast medium and normal saline to a total volume of 80-100 mL.
Sponsors
Tianjin Third Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years. 2. Hepatocellular carcinoma (HCC) confirmed by pathology or imaging, stage Ib–IIb according to the standard diagnostic and treatment guidelines for primary liver cancer, and not previously treated with or not suitable for surgical resection. 3. Liver function classified as Child–Pugh class A or B. 4. No severe dysfunction of major organs such as the heart, lungs, or kidneys, and able to tolerate interventional therapy. 5. Expected survival time >= 3 months. 6. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Imaging evidence of tumor thrombus in the portal vein or hepatic vein/inferior vena cava. 2. Presence of extensive extrahepatic metastases or diffuse liver cancer lesions for which local interventional therapy is not feasible. 3. Poor general condition or cachexia, with a short estimated survival time. 4. Severe hepatic or renal dysfunction. 5. Concomitant severe active infection or systemic inflammatory condition. 6. Concomitant other malignancies or a history of malignancy that may interfere with the evaluation of treatment efficacy. 7. Pregnant or breastfeeding women. 8. Known allergy to iodinated contrast agents or to any of the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of PES within 72 hours after the procedure (with severity graded according to CTCAE version 5.0);analgesic consumption;mean postoperative VAS pain score; | — |
Secondary
| Measure | Time frame |
|---|---|
| length of stay;changes in liver and renal function;radiologic response at 1–3 months after the procedure (assessed according to mRECIST); | — |
Countries
China
Contacts
Public ContactKefeng Jia
Tianjin Third Central Hospital
Outcome results
None listed