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Regional vs. Systemic Gemcitabine Chemotherapy for Unresectable Pancreatic Cancer

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Study Aim

This study aims to compare the effectiveness of regional versus systemic gemcitabine chemotherapy on overall survival in individuals with unresectable pancreatic cancer.

What is being tested

regional interventional chemotherapy group

Procedure
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Endocrine System Diseases

From 18 to 80 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorAir Force Military Medical University, China
Study ContactJun Tie, PH.D., MDMore contacts
Last updated: August 15, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

Advanced pancreatic cancer patients often face limited benefits from traditional chemotherapy using cytotoxic drugs. For over two decades, Gemcitabine has been the go-to first-line drug for treating advanced pancreatic cancer. Researchers have tried combining Gemcitabine with various other chemotherapeutic drugs to enhance treatment outcomes, but there hasn't been a significant improvement in patient survival. This study explores a different approach called locoregional chemotherapy, which involves delivering drugs directly to the affected area via an artery. The study's main goal is to determine if this method has a better tumor-fighting effect than traditional systemic chemotherapy, potentially improving care for patients with inoperable pancreatic cancer.

NCT01665625
Principal SponsorAir Force Military Medical University, China
Study ContactJun Tie, PH.D., MDMore contacts
Last updated: August 15, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms

Criteria

6 inclusion criteria required to participate
Expected survival > 3 months
Karnofsky score > 60
Liver, kidney function and routine blood test within normal range
No acute infection
Show More Criteria
4 exclusion criteria prevent from participating
Past or the presence of other malignancy
Pregnant or lactating women
Those who had received immunosuppressive therapy
Uncontrolled internal diseases

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

No Intervention

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, ChinaOpen Xijing Hospital of Digestive Diseases, Fourth Military Medical University in Google Maps

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, China
Suspended2 Study Centers