Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University

About this trial

Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years, regardless of gender;

Histopathologically confirmed or clinically diagnosed hepatic malignancies, including primary liver cancer and metastatic liver cancer;

Presence of an image-evaluable target lesion for ablation, with the maximum diameter of the target lesion being 3-5 cm;

Patient is intolerant to or refuses surgical resection;

Disqualifiers

Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy;

Massive or diffuse hepatocellular carcinoma;

Presence of vascular tumor thrombus or invasion of adjacent organs;

History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Multimodal Tumor Thermal Ablation

    Device

    Multimodal Tumor Thermal Ablation

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ablation efficacy rate at 1 month postoperatively

Ablation efficacy rate at 1 month postoperatively

Time frame
1 month after ablation

Secondary outcomes

1

Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment

Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment

Time frame
1 month after ablation
2

Adverse events and serious adverse events

Adverse events and serious adverse events

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.