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

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Multi-mode thermal ablation deviceDEVICE

The tumor tissue was rapidly frozen until the ice ball exceeded 5mm of the lesion tissue, kept for 5 minutes, then thawed and warmed. Then, complete ablation was performed according to the radiofrequency temperature control mode of multimodal tumor therapy to ensure that the ablation area included a safe range of 5\~10mm around the tumor.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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. refractory ascites, pleural fluid or bad fluid; 7. Pregnancy or breastfeeding; 8. The researcher considers that there are any other factors that are not suitable for inclusion or affect the participant's participation in the study.

Outcomes

Primary Outcomes

Safety and efficacy assessment

To evaluate the safety and efficacy of multimodal ablation therapy combined with immunotherapy

Time frame: Up to 1 year after the treatment

Secondary Outcomes

Survival benefit

Effect on survival benefit of pancreatic cancer patients with liver metastasis