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Trial Title:
TACE With Thermosensitive Nanogel Versus Embosphere for HCC
NCT ID:
NCT06593964
Condition:
Unresectable Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular carcinoma
Transarterial Chemoembolization
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Thermosensitive Nanogel Embolic Agent
Description:
Thermosensitive Nanogel Embolic Agent
Arm group label:
TACE with Embosphere Microspheres
Arm group label:
TACE with Thermosensitive Nanogel Embolic Agent
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gao-Jun Teng
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Gao-Jun Teng, MD
Start date:
September 10, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Zhongda Hospital
Agency class:
Other
Source:
Zhongda Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06593964
