Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-25 @ 4:27 PM
Study NCT ID:
NCT05687357
Status:
RECRUITING
Last Update Posted:
2023-04-19
First Post:
2022-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
Study Overview
Official Title:
Tislelizumab in Combination With Pre-operative Chemoradiotherapy Versus SOC for Patients With Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Multicenter, Randomized, Open-label, Phase IIB Trial
Status:
RECRUITING
Status Verified Date:
2022-10
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:
The purpose of this study is to evaluate the efficacy of Tislelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
The primary study hypotheses are that:
Neoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.
The primary study hypotheses are that:
Neoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of 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?: