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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
ID06296706

Phase III Randomized Trial Comparing Albumin-bound Docetaxel and Taxotere for Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2024-11-14

630

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This trial is a phase III, multicenter, randomized, controlled study evaluating treatments for patients with locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have experienced failure of first-line treatment. The study compares two chemotherapy drugs, Docetaxel for Injection Albumin-bound and Taxotere, to assess their effectiveness and safety in this patient population. Approximately 630 patients will be randomly assigned to receive either Docetaxel for Injection Albumin-bound or Taxotere. Both drugs will be given by intravenous infusion once every three weeks. Treatment will continue until the disease progresses. Regular visits and imaging scans will be conducted to monitor and compare the outcomes and side effects between the two treatment groups. Participants will have scheduled visits for imaging tests to assess tumor response and disease progression. Researchers will measure overall survival, tumor response rates, progression-free survival, disease control rates, duration of response, and the frequency and severity of any adverse events. Blood samples will be collected to analyze drug concentrations. The study will continue until disease progression, with ongoing monitoring to evaluate treatment effects and safety.

CONDITIONS

Brief Title

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

Research Team

C

Clinical Trials Information Group officer

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