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)
Disease control rate (DCR) — One month after the last TACE Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST).
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.
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