Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
Study NCT ID:
NCT05994456
Status:
UNKNOWN
Last Update Posted:
2023-08-16
First Post:
2023-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Toripalimab for dMMR/MSI-H Gastric Cancer
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Neoadjuvant Toripalimab in the Treatment of Locally Advanced dMMR/MSI-H Gastric or Gastroesophageal Junction Adenocarcinoma：an Open-label, Single-arm，Multi-center，Phase II Trial
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
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 is a single-center, open phase II clinical trial to evaluate the tolerability, safety and efficacy of toriparib monotherapy in the treatment of locally advanced dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.
Detailed Description:
In this phase II study, eligible patients are enrolled to receive toripalimab 240mg, ivdrip, Q3W to evaluate the anti-tumor efficacy and safety. After 2 and 4 cycles of toripalimab treatment, tumors are assessed, and patients are assigned to receive surgery or withdraw from study according to their anti-tumor efficacy. For patients withdrawing from study, routine treatment would be given. For patients staying in study, toripalimab would be administered for up to 2 years.
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?: