Using a new gel for treating liver cancer

Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial

This study is testing a new gel treatment for liver cancer to see if it works better than the standard method for patients who can't have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhongda Hospital (Academic / other)
• Locations: 1 site (Nanjing)
• Trial ID: NCT06593964 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of a Thermosensitive Nanogel Embolic Agent in transarterial chemoembolization (TACE) for patients with unresectable hepatocellular carcinoma (HCC). It is a multicenter, randomized controlled trial where participants will be assigned to either the experimental group receiving the new gel or the control group receiving standard Embosphere microspheres. The primary goal is to assess the disease control rate of the target lesions one month after the last TACE treatment. This approach seeks to improve treatment outcomes for patients who cannot undergo surgery.

Who should consider this trial

Good fit: Ideal candidates include patients with stage IIb-Illa HCC or stage Ia-Ila who are unsuitable for surgical resection, transplantation, or ablation.

Not a fit: Patients with prior embolization of the target lesion, diffuse disease, or severe liver dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for managing unresectable liver cancer.

How similar studies have performed: Other studies have explored similar approaches in liver cancer treatment, but the specific use of Thermosensitive Nanogel in TACE is relatively novel.

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.

Where this trial is running

Nanjing

• Gao-Jun Teng — Nanjing, China (Recruiting)

Study contacts

• Principal investigator: Gao-Jun Teng, M.D. — Zhongda Hospital
• Study coordinator: Lei Zhang, M.D.

Conditions Unresectable Hepatocellular Carcinoma; Hepatocellular carcinoma; Transarterial Chemoembolization