TACE With Thermosensitive Nanogel Versus Embosphere for HCC

Launched by ZHONGDA HOSPITAL · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for patients with unresectable hepatocellular carcinoma (HCC), which is a type of liver cancer that cannot be removed through surgery. The study is comparing two methods of delivering a treatment: one using a special substance called thermosensitive nanogel and the other using a product called Embosphere. The main goal is to see how safe and effective the thermosensitive nanogel is for patients who have certain types of liver tumors.

To join the trial, participants generally need to be between the ages of 65 and 74 and have specific forms of liver cancer that are not suitable for surgery. They should have at least one measurable tumor in their liver and good overall liver function. Participants in the trial will receive treatment and be monitored closely for any side effects or improvements in their condition. It’s important for potential participants to discuss all eligibility requirements and any questions with their doctor before deciding to take part.

Gender

ALL

Eligibility criteria

• 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.