Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 11:28 PM
Study NCT ID:
NCT07072351
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiotherapy Combined With Immunochemotherapy for Conversion Treatment of Gastroesophageal Junction Adenocarcinoma
Sponsor:
West China Hospital
Organization:
Study Overview
Official Title:
A Phase Ib/II Study of Hypofractionated Radiotherapy Combined With Immunochemotherapy as Conversion Therapy for Locally Advanced Gastroesophageal Junction Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2025-07
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:
The purpose of this study is to investigate the safety and efficacy of conversion therapy using HFRT combined with ICT in locally advanced or metastatic unresectable GEJA.
Detailed Description:
The aim of this study is to investigate whether hypofractionated radiotherapy (HFRT) combined with a PD-1 inhibitor (Sintilimab) and chemotherapy based on the SOX regimen is a safe and well-tolerated conversion strategy for patients with locally advanced or metastatic unresectable gastroesophageal junction adenocarcinoma (GEJA), and whether it can improve the objective response rate (ORR) compared to immunochemotherapy alone.
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?:
None
Is an FDA AA801 Violation?: