Clinical trial NCT06593964: TACE With Thermosensitive Nanogel Versus Embosphere for HCC
Official title: Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unresectable Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Transarterial Chemoembolization
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease control rate (DCR)
timeFrame: One month after the last TACE
Secondary outcomes:
measure: Success rate of target lesion embolization
timeFrame: One month after the last TACE
measure: Objective response rate (ORR)
timeFrame: One month after the last TACE treatment
measure: Disease control rate (DCR)
timeFrame: Three and six months after the first TACE
measure: Equipment performance evaluation
timeFrame: One month after the first TACE
measure: Adverse events
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Gao-Jun Teng
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng, M.D.
role: PRINCIPAL_INVESTIGATOR
References: