RecruitingPhase 4NCT05035147

Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer

Non-inferiority Study of Albumin-bound Paclitaxel Combined With Gemcitabine for Three Weeks Versus Four Weeks for First-line Inoperable Locally Advanced or Metastatic Pancreatic Cancer


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

934 participants

Start Date

Mar 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to further observe and evaluate whether the three-week administration of albumin-bound paclitaxel combined with gemcitabine is equivalent to the four-week administration in the treatment of inoperable locally advanced or metastatic pancreatic cancer


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two chemotherapy drugs — nab-paclitaxel (albumin-bound paclitaxel) and gemcitabine — as a first-line treatment for pancreatic cancer that cannot be removed by surgery. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic pancreatic cancer (not the islet cell type) confirmed by biopsy - You have not had chemotherapy for this cancer before (or it has been more than 6 months since finishing post-surgery treatment) - Your major organs (kidneys, liver, blood counts) are functioning well - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had another cancer (except cured skin or cervical in-situ cancer) - You are allergic to paclitaxel or gemcitabine - You have significant fluid buildup in your abdomen - You had a blood clot (stroke, deep vein clot, or pulmonary embolism) in the past 6 months - You have active hepatitis B or C 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

DRUGalbumin-bound paclitaxel

Experimental:Albumin-bound paclitaxel combined with gemcitabine was administered on the first and eighth day, a cycle of three weeks Active Comparator: Albumin-bound paclitaxel combined with gemcitabine was administered on the first, eighth, and fifteenth days, with a four-week cycle


Locations(1)

Rui Liu

Tianjin, Tianjin Municipality, China

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NCT05035147


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