RecruitingPhase 3NCT05653453

Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer


Sponsor

Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

Enrollment

512 participants

Start Date

Dec 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The Objectives of this clinical trial is to evaluate the efficacy and safety of tumor treating fields combined with gemcitabine and albumin bound paclitaxel in the treatment of locally advanced pancreatic cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a device called Tumor Treating Fields (a wearable device that uses electrical fields to slow cancer growth) to standard chemotherapy improves outcomes in patients with locally advanced pancreatic cancer that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with pancreatic cancer (adenocarcinoma) confirmed by biopsy - Your cancer is locally advanced (grown into nearby blood vessels) but has not spread to distant organs - Your overall health is good enough to receive chemotherapy (ECOG score 0–1) - Your expected survival is at least 3 months - You have not yet received any treatment for your pancreatic cancer **You may NOT be eligible if...** - You have already received chemotherapy for pancreatic cancer - You are allergic to gemcitabine or albumin-bound paclitaxel (the chemotherapy drugs used) - You have another active cancer (except certain treated early-stage cancers) - Your blood counts, liver, kidney, or heart function are significantly abnormal - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel

Device: Tumor treating fields Subjects will use tumor treating fields until disease progression or for a maximum of 30 months. Drug: Gemcitabine hydrochloride and albumin binding paclitaxel Subjects will receive Gemcitabine hydrochloride and albumin binding paclitaxel until disease progression or for a maximum of 30 months.

DRUGGemcitabine hydrochloride and albumin binding paclitaxel

Drug: Gemcitabine hydrochloride and albumin binding paclitaxel Subjects will receive Gemcitabine hydrochloride and albumin binding paclitaxel until disease progression or for a maximum of 30 months.


Locations(5)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, China

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05653453


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