Ignite Creation Date:
2024-05-06 @ 10:02 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03144843
Status:
UNKNOWN
Last Update Posted:
2017-05-09
First Post:
2017-05-05
Brief Title:
Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase II Multicenter Randomized Double-blind Study of Apatinib Combined With Paclitaxol Versus Placebo With Paclitaxol as Second Line Therapy for Advanced Gastric Esophagogastric Junction Adenocarcinoma With Peritoneal Metastasis
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multicenter randomized double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis
Patients will be randomized to one treatment arm Arm A apatinib 500mg qd Paclitaxol 80mgm2 d1 d8 d15every 4 weeks Arm B placebo 500mg qd Paclitaxol 80mgm2 d1 d8 d15every 4 weeks Tumor assessment will be done every 8 weeks according to RECIST 11 The primary endpoint is progression free survival PFS
Patients will be randomized to one treatment arm Arm A apatinib 500mg qd Paclitaxol 80mgm2 d1 d8 d15every 4 weeks Arm B placebo 500mg qd Paclitaxol 80mgm2 d1 d8 d15every 4 weeks Tumor assessment will be done every 8 weeks according to RECIST 11 The primary endpoint is progression free survival PFS
Detailed Description:
Gastric cancer is the second most common cause of cancer-related deaths worldwide and most patients are diagnozed at advanced stage in China Peritoneal metastasis is the most common metastatic site For gastric cancer patients with peritoneal metastasis chemotherapy can bring survival benefit versus best sportive care Paclitaxol is the standard second line chemotherapy for advanced gastric cancer patients
Apatinib mesylate is a small-molecule vascular endothelial growth factor receptor-2 VEGFR-2 tyrosine kinase inhibitor TKI It has been approved as third-line treatment for patients with advanced gastric adenocarcinoma in China
This multicenter randomized double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis
Apatinib mesylate is a small-molecule vascular endothelial growth factor receptor-2 VEGFR-2 tyrosine kinase inhibitor TKI It has been approved as third-line treatment for patients with advanced gastric adenocarcinoma in China
This multicenter randomized double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None