Status:
RECRUITING
TACE With Thermosensitive Nanogel Versus Embosphere for HCC
Lead Sponsor:
Zhongda Hospital
Conditions:
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
NA
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，w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06593964
Start Date
September 10 2024
End Date
April 30 2026
Last Update
September 19 2024
Active Locations (1)
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1
Gao-Jun Teng
Nanjing, China