Clinical trial · Interventional
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies
NCT07459309CI-TRIAL-00117309recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Ablation | — | UNRESOLVED | — |
| Liver Cancer (Primary and Metastatic) | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Tumor Thermal Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Multimodal Tumor Thermal Ablation
- interventionNames
- Device: Multimodal Tumor Thermal Ablation
Primary outcomes (1)
- measure
- Ablation efficacy rate at 1 month postoperatively
- timeFrame
- 1 month after ablation
- description
- Ablation efficacy rate at 1 month postoperatively
Secondary outcomes (2)
- measure
- Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment
- timeFrame
- 1 month after ablation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.