Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04367025
Status:
UNKNOWN
Last Update Posted:
2020-04-29
First Post:
2020-04-17
Brief Title:
Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody in Gastric Cancer
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody Camrelizumabin the Locally Advanced Adenocarcinoma of Stomach or Gastroesophageal Junction
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
NOT_YET_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:
For locally advanced gastric cance neoadjuvant chemotherapy can increase the resectability of tumor and finally improve the long-term survival
Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate CamrelizumabSHR-1210 in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma
This study is a single center open-label randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy
Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate CamrelizumabSHR-1210 in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma
This study is a single center open-label randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy
Detailed Description:
Gastric cancer is one of the most common malignancies in China with incidence and mortality both ranking the 2nd among malignancies in China Surgery is the only possible way to cure gastric cancer however over 80-90 of gastric cancer patients in China are in advanced stage Locally advanced gastric cancer could be cured by multi-disciplinary therapies including surgery chemotherapy and radiotherapy Neoadjuvant chemotherapy can increase the resectability of tumor and finally improve the long-term survival However the therapeutic effects remain unsatisfactory
Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate Camrelizumab in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma This study is a single center open-label randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy
Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate Camrelizumab in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma This study is a single center open-label randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy
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?:
None