Clinical Comparative Study Of Systematic Therapy Combined With MWA And Systematic Therapy For Pancreatic Cancer

Study Overview

Clinical Comparative Study of Systematic Therapy Combined With MWA 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. 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.

Pancreatic Neoplasms
Ablation

PROCEDURE: Systematic Therapy Combined With Microwave Ablation

82171941

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 2023-12-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-21
First Submitted that Met QC Criteria 2024-01-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-01-30
First Posted (ACTUAL) 2024-01-30	Results First Posted N/A	Last Verified 2024-01

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:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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
: Systematic Therapy Using the same chemotherapy method as the experimental group	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

Participant Group/Arm

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

: Systematic Therapy

Using the same chemotherapy method as the experimental group

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

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

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

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: Ping Liang

Phone Number: 66939530

Email: liangping301@hotmail.com

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:

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

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

Collaborators and Investigators

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

Investigators

STUDY_CHAIR: Ping Liang, The Fifth Medical Center of the General Hospital of the PLA of China

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

Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
Kluger MD, Epelboym I, Schrope BA, Mahendraraj K, Hecht EM, Susman J, Weintraub JL, Chabot JA. Single-Institution Experience with Irreversible Electroporation for T4 Pancreatic Cancer: First 50 Patients. Ann Surg Oncol. 2016 May;23(5):1736-43. doi: 10.1245/s10434-015-5034-x. Epub 2015 Dec 29.
Wang Z, Liu M, Zhang DZ, Wu SS, Hong ZX, He GB, Yang H, Xiang BD, Li X, Jiang TA, Li K, Tang Z, Huang F, Lu M, Chen JA, Lin YC, Lu X, Wu YQ, Zhang XW, Zhang YF, Cheng C, Ye HL, Wang LT, Zhong HG, Zhong JH, Wang L, Chen M, Liang FF, Chen Y, Xu YS, Yu XL, Cheng ZG, Liu FY, Han ZY, Tang WZ, Yu J, Liang P. Microwave ablation versus laparoscopic resection as first-line therapy for solitary 3-5-cm HCC. Hepatology. 2022 Jul;76(1):66-77. doi: 10.1002/hep.32323. Epub 2022 Jan 28.
Fegrachi S, Walma MS, de Vries JJJ, van Santvoort HC, Besselink MG, von Asmuth EG, van Leeuwen MS, Borel Rinkes IH, Bruijnen RC, de Hingh IH, Klaase JM, Molenaar IQ, van Hillegersberg R. Safety of radiofrequency ablation in patients with locally advanced, unresectable pancreatic cancer: A phase II study. Eur J Surg Oncol. 2019 Nov;45(11):2166-2172. doi: 10.1016/j.ejso.2019.06.008. Epub 2019 Jun 12.
Martin RC 2nd, Kwon D, Chalikonda S, Sellers M, Kotz E, Scoggins C, McMasters KM, Watkins K. Treatment of 200 locally advanced (stage III) pancreatic adenocarcinoma patients with irreversible electroporation: safety and efficacy. Ann Surg. 2015 Sep;262(3):486-94; discussion 492-4. doi: 10.1097/SLA.0000000000001441.
Vogl TJ, Panahi B, Albrecht MH, Naguib NNN, Nour-Eldin NA, Gruber-Rouh T, Thompson ZM, Basten LM. Microwave ablation of pancreatic tumors. Minim Invasive Ther Allied Technol. 2018 Feb;27(1):33-40. doi: 10.1080/13645706.2017.1420664. Epub 2017 Dec 26.

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