Clinical Study Of Multimodal Ablation Remodeling Immunosensitized PD-1 In The Treatment Of Pancreatic Cancer With Liver Metastasis

Study Overview

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

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.

N/A

Pancreatic Cancer

DEVICE: Multi-mode thermal ablation device
DRUG: Intravenous anti-PD-1 and chemotherapy

IIT2023-064

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-02-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-13
First Submitted that Met QC Criteria 2024-03-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-16
First Posted (ACTUAL) 2024-03-12	Results First Posted N/A	Last Verified 2024-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy Multimodal ablation therapy +PD-1 antibody combined with intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)	DEVICE: Multi-mode thermal ablation device 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 therap DRUG: Intravenous anti-PD-1 and chemotherapy intravenous anti-PD-1 and chemotherapy
ACTIVE_COMPARATOR: Intravenous anti-PD-1 and chemotherapy Intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)	DEVICE: Multi-mode thermal ablation device 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 therap DRUG: Intravenous anti-PD-1 and chemotherapy intravenous anti-PD-1 and chemotherapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy

Multimodal ablation therapy +PD-1 antibody combined with intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)

DEVICE: Multi-mode thermal ablation device

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 therap

DRUG: Intravenous anti-PD-1 and chemotherapy

intravenous anti-PD-1 and chemotherapy

ACTIVE_COMPARATOR: Intravenous anti-PD-1 and chemotherapy

Intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks)

DEVICE: Multi-mode thermal ablation device

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 therap

DRUG: Intravenous anti-PD-1 and chemotherapy

intravenous anti-PD-1 and chemotherapy

Primary Outcome Measures	Measure Description	Time Frame
Safety and efficacy assessment	To evaluate the safety and efficacy of multimodal ablation therapy combined with immunotherapy	Up to 1 year after the treatment

Secondary Outcome Measures	Measure Description	Time Frame
Survival benefit	Effect on survival benefit of pancreatic cancer patients with liver metastasis	Up to 1 year after the treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Long Jiang, MD

Phone Number: 18017317460

Email: jiang.long@shgh.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Long Jiang, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record