RecruitingPhase 3NCT06296706

A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer

A Multicenter, Randomized, Controlled Phase III Clinical Study of Docetaxel for Injection (Albumin-bound) Versus Taxotere in Gastric Cancer


Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Enrollment

630 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new form of docetaxel (a chemotherapy drug) bound to albumin protein in patients with advanced stomach or gastroesophageal junction cancer that has progressed after first-line treatment. **You may be eligible if...** - You are 18–75 years old with confirmed stomach cancer or cancer of the junction between the stomach and esophagus - Your cancer has worsened after first-line treatment (platinum and fluorouracil-based chemotherapy, with or without immunotherapy) - You have at least one measurable tumor on scans - Your general health is good (ECOG score 0–1) and key organ functions are adequate - You have a life expectancy of at least 3 months - You are willing to use contraception and not donate sperm if male **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your HER2 status is positive but you have not received anti-HER2 therapy - Your major organ function (liver, kidneys, bone marrow) does not meet required minimums - You have previously received docetaxel 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

DRUGDocetaxel for injection (Albumin-bound)

Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks

DRUGTaxotere (docetaxel)

Taxotere, by intravenous infusion, every 3 weeks.


Locations(1)

CSPC Zhongqi Technology(SJZ) Ltd

Shijiazhuang, Hebei, China

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NCT06296706


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