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Recruiting NCT06307080

NCT06307080 Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis

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Clinical Trial Summary
NCT ID NCT06307080
Status Recruiting
Phase
Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Condition Pancreatic Cancer
Study Type INTERVENTIONAL
Enrollment 12 participants
Start Date 2023-10-08
Primary Completion 2025-12-31

Trial Parameters

Condition Pancreatic Cancer
Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Type INTERVENTIONAL
Phase N/A
Enrollment 12
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-10-08
Completion 2025-12-31
Interventions
Multi-mode thermal ablation deviceIntravenous anti-PD-1 and chemotherapy

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Brief Summary

1. Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies. 2. Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy. 3. Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.

Eligibility Criteria

Inclusion Criteria: 1. age 18-70 years old, gender is not limited; 2. Newly diagnosed pancreatic cancer with liver metastasis confirmed by pathology or consistent with clinical diagnosis, and no metastases to organs other than the liver; 3. Imaging evaluable tumors with safe access to puncture; 4. The number of half liver tumors ≤3 and the size of each tumor ≤3 cm; 5. ECOG PS score ≤2 points, expected survival \> 3 months. Exclusion Criteria: 1. Liver function Child-Pugh grade C, severe jaundice, especially obstructive jaundice; 2. The liver is significantly atrophy, the tumor is too large, and the ablation range needs to reach one-third of the liver volume; 3. Expected survival \< 3 months; 4. serious heart, lung, liver and kidney dysfunction and coagulation dysfunction; 5. Uncontrolled co-morbidities, including poorly controlled hypertension or diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study; 6. re

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