Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555471
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
A Single-arm Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is a prospective single-arm single-centre phase II clinical study to explore the efficacy and safety of sintilimab in combination with chemoradiation in subjects over 75 years of age with advanced gastric cancer
Participants will
Take sintilimab 200mg iv q3w d1 combined with chemoradiation The application of chemotherapy based on investigators assessment and if so S-1 po d1-d14q3w according to body surface area 15m2 40mgtime1518m2 50mgtime18m2 60mgtime or capecitabine 1000mgm2 Bid po d1-14q3wReduce or discontinue depending on the condition of the subject Radiotherapyonce a day five times a week at a dose of 18-2 Gyf for a total of 45-504 Gy Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy
Subjects undergo an initial assessment of imaging physical status quality of life and relevant laboratory tests after completion of 3 cycles of sintilimab combination chemotherapy followed by assessments every 2 months and after 3 full assessments assessments every 3 months are initiated
Participants will
Take sintilimab 200mg iv q3w d1 combined with chemoradiation The application of chemotherapy based on investigators assessment and if so S-1 po d1-d14q3w according to body surface area 15m2 40mgtime1518m2 50mgtime18m2 60mgtime or capecitabine 1000mgm2 Bid po d1-14q3wReduce or discontinue depending on the condition of the subject Radiotherapyonce a day five times a week at a dose of 18-2 Gyf for a total of 45-504 Gy Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy
Subjects undergo an initial assessment of imaging physical status quality of life and relevant laboratory tests after completion of 3 cycles of sintilimab combination chemotherapy followed by assessments every 2 months and after 3 full assessments assessments every 3 months are initiated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None