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

StatusRecruiting
PhasePhase 3
Started2024-02-27
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 14, 2024 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2024-11-12
notable
Enrolling by Invitation→Recruiting Study Status, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusEnrolling by Invitation→Recruiting
Start date2024-03-01→2024-02-27
Eligibility criteria+33 characters
Inclusion Criteria: 1. Age: 18-75 years (inclusive) (Whichever is on the day of signing the informed consent form). 2. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology. 3. Locally advanced or metastatic gastric adenocarcinoma or ade [...] ing dual drug chemotherapy, with or without immunotherapy). 4. Evidence of disease progression on imaging during or after the last systemic treatment as confirmed by investigator. 5. At least one assessable lesion according to RECIST V1.1; the [...] te progress of the lesion after completion of radiotherapy. 6. Previo [...] [...]
Secondary endpoints7 to 6 entries
ORR The by IRC ORR by investigator AEincidence and severity of adverse events (AE) and severe adverse events (SAE)
Primary endpoints2 to 1 entries
PFS
Study sitesdetails revised at 1 of 1 site
2024-09-25
notable
Not Yet Recruiting→Enrolling by Invitation Study Status, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Study sites0→1
Eligibility criteria-109 characters
[...] o sign a written informed consent form. Exclusion Criteria: Diagnosed as Krukenberg tumor, unless radical resection has been performed and there is no visible tumor residue. Medical history of other malignant tumors or other active ma [...] of ≥ Grade Ⅱ or left ventricular ejection fraction (LVEF) of<&lt;50%; 4) Long QTc syndrome or QTc interval>&gt;480 milliseconds, as well as the use of any known concomitan [...] lic blood pressure ≥ 100 mmHg during the screening period). 87. History of gastrointestinal perforation and/or fistula within 6 months before randomization. 98. Patients with active hepatitis B(H [...] [...]
Secondary endpointsdetails revised at 1 of 7 entries
Primary endpoints1 to 2 entries
PFS
2024-03-04
minor
Original filing
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.
Trial Details
NCT Number NCT06296706
Lead Sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions Gastric Cancer
Enrollment 630 participants
Start Date 2024-02-27
Primary Completion 2026-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-14