Liver Ablation, Liver Cancer (Primary and Metastatic)
Conditions
Brief summary
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies
Interventions
DEVICEMultimodal Tumor Thermal Ablation
Multimodal Tumor Thermal Ablation
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years, regardless of gender; 2. Histopathologically confirmed or clinically diagnosed hepatic malignancies, including primary liver cancer and metastatic liver cancer; 3. Presence of an image-evaluable target lesion for ablation, with the maximum diameter of the target lesion being 3-5 cm; 4. Patient is intolerant to or refuses surgical resection; 5. ECOG performance status score ≤ 2, with an expected survival period of greater than 3 months.
Exclusion criteria
1. Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy; 2. Massive or diffuse hepatocellular carcinoma; 3. Presence of vascular tumor thrombus or invasion of adjacent organs; 4. History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment; 5. Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding; 6. Refractory massive ascites, cachexia; 7. Active infection, especially inflammatory conditions of the biliary system; 8. Severe functional failure of major organs such as liver, kidney, heart, lung, and brain; 9. Impaired consciousness, or inability to cooperate with treatment; 10. Previous systemic treatments (e.g., chemotherapy) with an interval of less than 2 weeks and not having recovered from prior treatment: CTCAE 6.0 grade \>1 (except for alopecia); 11. Any other factors deemed by the investigator to make the subject unsuitable for participation or to affect the subject's involvement in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ablation efficacy rate at 1 month postoperatively | 1 month after ablation | Ablation efficacy rate at 1 month postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment | 1 month after ablation | Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment |
| Adverse events and serious adverse events | 1 month | Adverse events and serious adverse events |
Countries
China
Contacts
CONTACTwentao li
Outcome results
None listed