Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475196
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab PD-1 Inhibitor Combined With Chemotherapy in Resectable ESCC
Sponsor:
Tang-Du Hospital
Organization:
Tang-Du Hospital
Study Overview
Official Title:
The Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab PD-1 Inhibitor Combined With Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
This study is an open-label prospective cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer In the study all subjects who meet the enrollment criteria will be randomized 111 to receive sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles Group A sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles sintilimab for 1 cycle Group B sintilimab combined with platinum-containing chemotherapy for 1 cycle sintilimab Q3W for 2 cycles Group B as neoadjuvant therapy and receive radical surgery within 4-6 weeks after the completion of the last neoadjuvant therapy Whether the subjects need adjuvant therapy and adjuvant treatment regimen after surgery are determined by the investigator and all subjects need to complete the follow-up plan formulated by the study after surgery
Detailed Description:
None
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