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Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis

Effectiveness and Safety Evaluation of Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis: A Prospective, Single-center, Single-arm, Phase II Clinical Study

NCT04677192•Fudan University

View on ClinicalTrials.gov

Summary

This study is a prospective, single center, single arm, phase II clinical study in patients with liver metastasis after radical resection of pancreatic cancer. The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.

Detailed Description

Microwave ablation, as one of the important treatment methods of liver metastases, has the advantages of radical effect, small trauma and rapid recovery.Microwave ablation combined with chemotherapy aims to improve the quality of life and prolong the survival time.The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age: 18 to 75years old, male or female;
•ECOG PS: 0-2 points;
•Patients with pancreatic ductal adenocarcinoma diagnosed by histology or cytology;
•Expected survival time\> 3 months;
•The functions of important organs meet the following requirements;
•The maximum diameter of single lesion ≤ 5cm or the number of multiple lesions ≤ 5 and the maximum diameter ≤ 3cm;
•Measurable lesions that meet RECIST criteria.
•1. Platelet ≥75×109/L, hemoglobin ≥85g/L，white blood cell ≥ 3.0 × 109 / L;
•2. Total bilirubin ≤ 1.5 times upper limit of normal value (ULN) ; ALT and AST ≤ 5 times ULN ;
•3. Albumin ≥ 28g / L;
+4 more criteria

Exclusion Criteria

•Patients with distant metastasis include but not limited to lung metastasis, bone metastasis and brain metastasis;
•Other serious diseases or conditions, including congestive heart failure (NYHA grade III or IV), unstable angina, myocardial infarction and cerebral infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, drug abuse, etc;
•Women who are pregnant or nursing, or have fertility but refuse to take contraceptive measures;
•During the enrollment period, a serious active infection requiring antibiotic intravenous treatment occurred;
•In addition to cervical carcinoma in situ, basal cell carcinoma and superficial bladder tumor (TA, tis \& T1). Any cancer cured for more than 3 years before enrollment was allowed to be enrolled;
•Patients who cannot follow the trial protocol or cannot cooperate with follow-up;

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 1, 2021

Primary Completion Date

January 1, 2022

Completion Date

December 1, 2022

Last Updated

December 21, 2020

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer Metastatic to LiverOligometastasis

Interventions

Microwave Ablation combination with chemotherapy

COMBINATION_PRODUCT

Contacts

Yongqiang Hua, Deputy chief physician

CONTACT

（021）64175590 keqiang1215@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis

Inclusion Criteria

Exclusion Criteria

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