Recruiting NCT07459309

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

No phase Interventional Liver Cancer (Primary and Metastatic) Liver Ablation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Multimodal Tumor Thermal Ablation.
Who it may be relevant to: Registry conditions: Liver Cancer (Primary and Metastatic), Liver Ablation. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Ablation efficacy rate at 1 month postoperatively [Time frame: 1 month after ablation]

Secondary outcome measures (2)

Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment [Time frame: 1 month after ablation]
Adverse events and serious adverse events [Time frame: 1 month]

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;
ECOG performance status score ≤ 2, with an expected survival period of greater than 3 months.

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;
Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding;
Refractory massive ascites, cachexia;
Active infection, especially inflammatory conditions of the biliary system;
Severe functional failure of major organs such as liver, kidney, heart, lung, and brain;
Impaired consciousness, or inability to cooperate with treatment;
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);
Any other factors deemed by the investigator to make the subject unsuitable for participation or to affect the subject's involvement in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

NCT: NCT07459309 · MTTIR-DHF-701