Radiofrequency-responsive Layered Double Hydroxides for Enhanced Arterial Embolization and Thermal Immunotherapy in Hepatocellular Carcinoma

NCT06966986 | Active Not Recruiting DMC

• 1 other identifier: KY-2024-140
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Liver cancer is one of the most common malignant tumors and the third leading cause of cancer-related deaths globally. Recent epidemiological studies show that in China, liver cancer ranks fourth in incidence and second in mortality among malignant tumors, posing a serious threat to human health. The common risk factors for liver cancer are chronic inflammatory infections caused by hepatitis B virus (HBV) and hepatitis C virus (HCV), which lead to liver cirrhosis and eventually develop into liver cancer. The field of liver cancer treatment is characterized by its multidisciplinary approach and the coexistence of various therapeutic methods. Common treatment modalities include liver resection, liver transplantation, ablation therapies, and transcatheter arterial chemoembolization (TACE). Selecting appropriate treatment strategies based on the different stages of liver cancer can maximize therapeutic outcomes. Although surgical intervention is considered the first-line curative treatment for liver cancer, a significant number of patients are unable to tolerate surgery due to varying degrees of liver cirrhosis and impaired liver function. The limited availability of treatment options results in a relatively low 5-year survival rate of approximately 18% for liver cancer patients. Liver cancer is insidious in onset, highly malignant, and progresses rapidly. Most patients are diagnosed at an advanced stage, having missed the optimal window for surgical resection. For these patients, interventional therapies based on transcatheter arterial embolization (TAE) have shown excellent antitumor effects and are gradually becoming essential treatment methods for advanced liver cancer. In TAE, embolic agents are injected into the tumor's supplying arteries via a catheter to block the tumor's oxygen and nutrient supply. Currently, embolic agents primarily include liquid embolics (e.g., lipiodol) and solid agents (e.g., microspheres). However, as a palliative treatment, TAE struggles to completely suppress tumor growth. This limitation arises because these embolic agents are unable to fully and permanently block all tumor vasculature, allowing tumors to establish collateral circulation after the procedure. Additionally, the hypoxic tumor microenvironment created post-procedure stimulates rapid proliferation of liver cancer cells. Consequently, it is critical to develop effective strategies to improve the outcomes of TAE. Radiofrequency ablation (RFA), a common thermal ablation method for liver cancer in clinical practice, has been widely applied. Leading medical associations, including the U.S. National Comprehensive Cancer Network (NCCN) and the Asia-Pacific Association for the Study of the Liver (APASL), have recognized RFA as a first-line treatment for solitary liver tumors ≤3 cm in size. During RFA, the central region of the tumor reaches temperatures above 50°C, inducing coagulative necrosis of solid tumors, while the surrounding area, referred to as the transition zone, experiences sublethal heat stress. However, incomplete radiofrequency ablation (iRFA) can occur due to factors such as large tumor size, thermal sink effects of blood vessels, and undetected micro-satellite lesions, leading to rapid recurrence or metastasis of residual tumor tissue. Studies have reported that RFA can induce specific immune responses by releasing tumor-associated antigens, damage-associated molecular patterns (DAMPs), and pro-inflammatory cytokines from denatured tumor cells. However, the antitumor immune response elicited by RFA is often transient and weak. Moreover, it may trigger a series of immunosuppressive responses, further complicating the overall therapeutic outcome.

Conditions

Liver Carcinoma

Keywords

Indocyanine green (ICG), radiofrequency ablation, microwave ablation, laparoscopy, liver cancer

Outcome Measures

Primary Outcomes (1)

• Immune

  Changes in the proportion of different immune cell subsets were detected, especially the number and functional status of CD8+ T cells, regulatory T cells (Tregs), and NK cells

  2024-2026

Secondary Outcomes (1)

• Immune

  2024-2026

Other Outcomes (1)

• Immune

  2024-2026

Study Arms (1)

treatment after RFA

These samples will be used to assess the state of the patient's immune response, focusing on the following areas: Immune cell subpopulation analysis: Analysis is performed by flow cytometry to detect changes in the proportion of different immune cell subpopulations, specifically the number and functional status of CD8+ T cells, regulatory T cells (Tregs), and NK cells. Simulated radiofrequency ablation was performed in vitro, focusing on changes in the ablation range.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical data of patients undergoing radiofrequency ablation of liver cancer in the Fourth Affiliated Hospital of Zhejiang University were collected

You may qualify if:

• individual tumors were less than 5 cm in diameter. The number of multiple tumors was not more than 3, and the diameter of each tumor was not more than 3 cm, and there was no extrahepatic metastasis. Child-Pugh A or B; There is no refractory ascites or irremediable coagulation dysfunction; Prothrombin activity higher than 40%, platelet count more than 500,000/L; RFA with healing purpose.

You may not qualify if:

• presence of vascular infiltration and extrahepatic metastasis; Severe clotting disorders; Severe cardiopulmonary insufficiency or uncontrolled liver decompensation.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: May 13, 2025
• Study Start: September 11, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)