TACE With Thermosensitive Nanogel Versus Embosphere for HCC

Southeast University

Status: Enrolling

Conditions: Unresectable Hepatocellular Carcinoma

Treatments: Device: Thermosensitive Nanogel Embolic Agent

Study type: Interventional

Funder types: Other

Identifiers

NCT06593964

CHANCE-2416

Details and patient eligibility

About

To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.

Full 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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

TACE with Thermosensitive Nanogel Embolic Agent

Experimental group

Description:

Equipment: Thermosensitive Nanogel Embolic Agent

Treatment:

Device: Thermosensitive Nanogel Embolic Agent

TACE with Embosphere Microspheres

Active Comparator group

Description:

Equipment: Embosphere Microspheres

Treatment:

Device: Thermosensitive Nanogel Embolic Agent