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Recruiting NCT07459309

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

Conditions: Liver Cancer (Primary and Metastatic), Liver Ablation

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Fudan University

Location: Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality

Summary

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

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07459309). StuddyBuddy aggregates publicly available trial information.