Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-26 @ 11:32 PM
Study NCT ID:
NCT06667050
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAPOX Plus Sintilimab and Bevacizumab Biosimilar (IBI305) for Neoadjuvant Treatment of Locally Advanced Gastric Cancer
Sponsor:
West China Hospital
Organization:
Study Overview
Official Title:
CAPOX Combined with Sintilimab and Bevacizumab Biosimilar (IBI305) for Neoadjuvant Treatment of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Prospective, Multi-center, Single-arm, Phase II Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
Neoadjuvant chemotherapy has been recommended by a series of treatment guidelines for the neoadjuvant treatment of locally advanced G/GEJ cancer. Although with clinical efficacy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with sintilimab and bevacizumab biosimilar (IBI305) in the neoadjuvant treatment for locally advanced G/GEJ cancer.
Detailed Description:
This is a prospective, multicenter, single-arm, phase II trial. A total of 58 patients will be enrolled. Eligible patients will be registered and receive three cycles of CAPOX plus sintilimab and bevacizumab biosimilar (IBI305) regimen. Radical D2 gastric cancer resection will be performed 6-8 weeks after the last administration of chemotherapy plus plus sintilimab and bevacizumab biosimilar (IBI305). The primary endpoint of the study is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS) and safety profile of the neoadjuvant regimen.
Study Oversight
Has Oversight DMC:
False
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?: