TACE With Thermosensitive Nanogel Versus Embosphere for HCC

NCT ID: NCT06593964

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2026-04-30

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.

Conditions

Unresectable Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE with Thermosensitive Nanogel Embolic Agent

Equipment:

Thermosensitive Nanogel Embolic Agent

Group Type: EXPERIMENTAL

Thermosensitive Nanogel Embolic Agent

Intervention Type: DEVICE

Thermosensitive Nanogel Embolic Agent

TACE with Embosphere Microspheres

Equipment:

Embosphere Microspheres

Group Type: ACTIVE_COMPARATOR

Thermosensitive Nanogel Embolic Agent

Intervention Type: DEVICE

Thermosensitive Nanogel Embolic Agent

Interventions

Thermosensitive Nanogel Embolic Agent

Thermosensitive Nanogel Embolic Agent

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gao-jun Teng

Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gao-Jun Teng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Gao-Jun Teng

Nanjing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Zhang, M.D.

Role: CONTACT

llei589@126.com

+86 13770106862

Facility Contacts

Gao-Jun Teng, MD

Role: primary

Other Identifiers

CHANCE-2416

Identifier Type: -

Identifier Source: org_study_id