Unresectable Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, Transarterial Chemoembolization
Brief summary
To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.
Detailed description
This is a prospective, multicenter, randomized controlled, non-inferiority design trial. Participants who meet the criteria will be randomly assigned into the experimental group or the control group，with a ratio of 1:1. In the experimental group the Thermosensitive Nanogel Embolic Agent will be used in the TACE procedure, while in the control group the Embosphere microspheres will be used. The primary endpoint is disease control rate of the target lesions at 1 month after the last TACE treatment.
Interventions
DEVICEThermosensitive Nanogel Embolic Agent
Thermosensitive Nanogel Embolic Agent
Sponsors
Zhongda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation; 2. Liver function status: Child-Pugh A or B 3. Eastern Cooperative Oncology Group score: 0-2 points; 4. With at least one measurable, unembolized liver tumor lesion (1-10 cm) ; 5. Willing to participate in this trial and sign the informed consent.
Exclusion criteria
1. The target lesion has been embolized before or require combined with other treatment(s); 2. Diffuse or with extrahepatic metastasis; 3. Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds); 4. Severe renal dysfunctions (creatinine clearance rate \<30 ml/min); 5. Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times); 6. Main portal vein was completely occluded and no collateral blood supply was established; 7. With uncorrectable arteriovenous fistula or portal vein fistula; 8. Severe cachexia or hepatic encephalopathy; 9. With active infection; 10. Significant reductions in white blood cells or platelets (white blood cells\<3.0x109/L, platelets\<50x109/L) that cannot be corrected; 11. Pregnant or lactating women; 12. Difficulty in selective catheterization; 13. With the severe risk of non-target embolization; 14. Severely allergic to contrast agents or the embolic materials; 15. Participating in ongoing trial; 16. Unsuitable judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | One month after the last TACE | Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of target lesion embolization | One month after the last TACE | Success rate of target lesion embolization, evaluated by the investigator and independent image review committee respectively. |
| Objective response rate (ORR) | One month after the last TACE treatment | Objective response rate of target lesions, evaluated by the investigator and independent image review committee respectively (mRECIST). |
| Disease control rate (DCR) | Three and six months after the first TACE | Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST). |
| Equipment performance evaluation | One month after the first TACE | (Intraoperative imaging ability, microcatheter delivery capacity) evaluated by the investigator. |
| Adverse events | Up to 24 months | Rate of adverse events, evaluated by the investigator (CTACE 5.0) |
Countries
China
Contacts
Primary ContactLei Zhang, M.D.
Outcome results
None listed