Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05216237
Status:
RECRUITING
Last Update Posted:
2022-04-11
First Post:
2022-01-19
Brief Title:
A Study to Evaluate the Efficacy and Safety of Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative Microsatellite Stability MSS Advanced or Metastatic Gastric GC or Gastroesophageal Junction GEJ Cancer
Sponsor:
Jiuda Zhao
Organization:
Affiliated Hospital of Qinghai University
Study Overview
Official Title:
An Open-Label Multi-Center Phase II Study to Evaluate the Efficacy and Safety of PD-1 Antibody Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative MSS Advanced or Metastatic GC or GEJ Cancer
Status:
RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
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:
To evaluate the efficacy and safety of Sintilimab combined with apatinib and chemotherapy as First-line or second-line Therapy in Treatment of HER-2 negative MSS Advanced or Metastatic GC or GEJ Cancer At the same time the correlation between tissue programmed death ligand-1PD-L1 expression and blood circulating tumor cellCTC counts and the efficacy of immune combination therapy was also explored
Detailed Description:
Participants receive Sintilizumab 200 mg intravenously IV every 3 weeksQ3Wplus Apatinib 250 mg twice daily BID by continous oral adminstration for 14 days followed by a recovery period of 7 days plus Tegafur gimeracil oteracil potassium capsules 40mg for body surface area 125m2 50mgm2 for body surface area 125-15m2 60mg for body surface area 15m2 BID by continous oral adminstration for 14 days followed by a recovery period of 7 days plus Oxaliplatin 85 mgm2 IV Q3W for 4-6 cycles followed by Cindilizumab plus Tegafur gimeracil oteracil potassium capsules
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?:
False
Is an FDA AA801 Violation?:
None