This trial is a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
One hundred patients with locally advanced or metastatic gastric adenocarcinoma or gastric esophageal junction adenocarcinoma will be randomly assigned to the test group or the control group. All patients will receive Docetaxel for injection (Albumin-bound) or Taxotere for treatment until disease progression. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.
Taxotere, by intravenous infusion, every 3 weeks.
Ethics Committee of Sun-Yat-Sen University Cancer Center
Guangzhou, China
RECRUITINGProgression-Free-Survival (PFS)
The duration is from the randomized time to disease progression or death due to any reason.
Time frame: Up to approximately 2 years
Overall response rate (ORR)
The primary endpoint is objective response rate,which equals CR+PR.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
The primary endpoint is Disease Control rate,which equals CR+PR+SD.
Time frame: Up to approximately 2 years
Duration of Response (DoR)
The time from the first assessment of tumor as CR or PR to the first assessment as PD or death from any cause
Time frame: Up to approximately 2 years
Overall survival (OS)
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost
Time frame: Up to approximately 2 years
Incidence of AE and SAE
Time frame: Up to approximately 2 years
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