Ignite Creation Date:
2024-05-06 @ 1:45 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04119622
Status:
UNKNOWN
Last Update Posted:
2022-03-11
First Post:
2019-10-07
Brief Title:
Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer
Sponsor:
Aiping Zhou
Organization:
ChineseAMS
Study Overview
Official Title:
A Phase II Study of XELOX and Toripalimab in the Neoadjuvant Treatment of Stage IIIII Gastric or GE Junction Adenocarcinoma
Status:
UNKNOWN
Status Verified Date:
2022-03
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:
Gastric cancer GC is one of the most common malignancies According to the global cancer statistics 2018 there were 1033701 new cases of gastric cancer per year ranked the fifth place in new tumors and 782685 deaths ranked the second place in cancer deaths At present surgery is the only way to cure gastric cancer but the 5-year survival rate is only 20-30 studies have confirmed that neoadjuvant therapy could improve the R0 resection rate and overall survival which is considered a better treatment strategy
PD 1 monoclonal antibody is definitely effective in neoadjuvant therapy in other tumors such as NSCLC and bladder cancer especially in PD-L1 patients However there is no research of PD-1 monoclonal antibody in neoadjuvant therapy of gastric cancer Thus we plan to conduct this prospective phase II clinical trial evaluating the safety and efficacy of toripalimab also known as JS001 in combination with XELOX for the neoadjuvant therapy of gastric cancer
PD 1 monoclonal antibody is definitely effective in neoadjuvant therapy in other tumors such as NSCLC and bladder cancer especially in PD-L1 patients However there is no research of PD-1 monoclonal antibody in neoadjuvant therapy of gastric cancer Thus we plan to conduct this prospective phase II clinical trial evaluating the safety and efficacy of toripalimab also known as JS001 in combination with XELOX for the neoadjuvant therapy of gastric cancer
Detailed Description:
This phase II trial is a single-arm open Label non-randomized and single-center clinical study Patients who met the study criteria will receive the combination of toripalimab 240 mg d1 with XELOX oxaliplatin 130 mgm2 QD d1 capecitabine 1000 mgm2 BID d1-d14 of a 3-week treatment cycle up to two cycles After the second cycle of treatment clinical efficacy evaluation will be done by MDT according to iRECIST For patients with CRPRSD surgery will be performed within 4 weeks For patients with disease progress MDT will determine whether the surgery could be performed If resection could not be done the patients would receive Original chemotherapy with toripalimab for 1 more cycle chemoradiotherapy or the second line chemotherapy The primary endpoint is Major pathological response
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?:
False
Is an FDA AA801 Violation?:
None