RecruitingNot ApplicableNCT06593964
TACE With Thermosensitive Nanogel Versus Embosphere for HCC
Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
Sponsor
Zhongda Hospital
Enrollment
188 participants
Start Date
Sep 10, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria5
- 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;
- Liver function status: Child-Pugh A or B
- Eastern Cooperative Oncology Group score: 0-2 points;
- With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;
- Willing to participate in this trial and sign the informed consent.
Exclusion Criteria16
- The target lesion has been embolized before or require combined with other treatment(s);
- Diffuse or with extrahepatic metastasis;
- Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);
- Severe renal dysfunctions (creatinine clearance rate \<30 ml/min);
- Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times);
- Main portal vein was completely occluded and no collateral blood supply was established;
- With uncorrectable arteriovenous fistula or portal vein fistula;
- Severe cachexia or hepatic encephalopathy;
- With active infection;
- Significant reductions in white blood cells or platelets (white blood cells\<3.0x109/L, platelets\<50x109/L) that cannot be corrected;
- Pregnant or lactating women;
- Difficulty in selective catheterization;
- With the severe risk of non-target embolization;
- Severely allergic to contrast agents or the embolic materials;
- Participating in ongoing trial;
- Unsuitable judged by the investigator.
Interventions
DEVICEThermosensitive Nanogel Embolic Agent
Thermosensitive Nanogel Embolic Agent
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06593964
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