Clinical Comparative Study of Systematic Therapy Combined With MWA and Systematic Therapy for Pancreatic Cancer

January 21, 2024 updated by: Ping Liang, Chinese PLA General Hospital

Clinical Comparative Study of Systematic Therapy Combined With Microwave Ablation and Systematic Therapy for Pancreatic Cancer

Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Ablation has been confirmed one of the most effective methods for solid tumors by recent twenty years and proven to be a radical treatment similar to the surgical resection for the clinical applications of hepatic and renal tumors at early clinical staging in the internationally guidelines. The purpose is to explore the efficacy and safety of microwave ablation in the treatment of pancreatic cancer in combination with systematic therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Furthermore, it is difficult to achieve tumoral complete responses by traditional therapies including chemotherapy, radiotherapy and transarterial embolization. Ablation has been confirmed one of the most effective methods for solid tumors by recent twenty years and proven to be a radical treatment similar to the surgical resection for the clinical applications of hepatic and renal tumors at early clinical staging in the internationally guidelines. However, the published clinical practices on the thermal ablation of PCs with large-scale cases are rare. One of the most important reasons for this originates from the extreme complexity and difficult regulation of the temperature distribution in tumors during thermal ablation because of the own characteristics of PCs, including highly invasive growth without tumoral capsules, high proportion of the interstitial fiber tissue, and the unusual blood perfusion because of extremely chaotic microvascular structures. The purpose is to explore the efficacy and safety of microwave ablation in the treatment of pancreatic cancer in combination with systematic therapy.

Study Type

Observational

Enrollment (Estimated)

185

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pancreatic cancer

Description

Inclusion Criteria:

  • Inoperable pancreatic cancer
  • Age from 18 to 80
  • PS score from 0 to 3
  • Clear pathological diagnosis

Exclusion Criteria:

  • Severe coagulation dysfunction
  • Individuals with severe heart, lung, liver, and kidney dysfunction
  • Individuals with acute or active infectious lesions in any part of the body
  • Researchers believe that there are any other factors that are not suitable for inclusion or that affect the participation of participants in the study
  • Psychological health issues that hinder this experiment

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Systematic Therapy Combined With Microwave Ablation
Perform microwave ablation for patients with pancreatic cancer, and then conduct chemotherapy according to the guidelines two to three weeks later
Procedure: Systematic Therapy Combined With Microwave Ablation
Patients with unresectable pancreatic cancer were included for laboratory examination, and quality of life and pain scores were recorded. The experimental group underwent microwave ablation first, followed by chemotherapy according to the guidelines; The control group received the same chemotherapy. Record the use of chemotherapy drugs and the occurrence of adverse events. Follow up will be conducted at 30 days, 90 days, and 180 days after chemotherapy to evaluate pancreatic function and quality of life.
Other Names:
  • Systematic Therapy
Systematic Therapy
Using the same chemotherapy method as the experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 30, 90, and 180 days after the end of the last chemotherapy
Time from receiving treatment to death
30, 90, and 180 days after the end of the last chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief rate
Time Frame: 30, 90, and 180 days after the end of the last chemotherapy
Pain relief before and after treatment
30, 90, and 180 days after the end of the last chemotherapy

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Chair: Ping Liang, The Fifth Medical Center of the General Hospital of the PLA of China

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 24, 2023

First Submitted That Met QC Criteria

January 21, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82171941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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