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TACE With Thermosensitive Nanogel Versus Embosphere for HCC

RECRUITINGN/ASponsored by Zhongda Hospital
Actively Recruiting
PhaseN/A
SponsorZhongda Hospital
Started2024-09-10
Est. completion2026-04-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions4

CancerLiver CancerLiver DiseaseUnresectable Hepatocellular Carcinoma

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