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Clinical Trials in China / NCT06593964
Recruiting Not applicable

TACE With Thermosensitive Nanogel Versus Embosphere for HCC

NCT06593964 · tracked via the Priya Life Science China tracker
Sponsor
Zhongda Hospital
Phase
Not applicable
Started
2024-09-10
Last updated
2024-09-19

Condition(s) studied

Unresectable Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

Thermosensitive Nanogel Embolic Agent

Thermosensitive Nanogel Embolic Agent: Thermosensitive Nanogel Embolic Agent

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Gao-Jun Teng Nanjing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06593964 on ClinicalTrials.gov ↗ ← All trials in China