Ignite Creation Date:
2024-05-06 @ 1:40 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04098796
Status:
UNKNOWN
Last Update Posted:
2021-04-14
First Post:
2019-09-19
Brief Title:
PD-1 Antibody XELOX in 1st Line Serum A-fetoprotein AFP-Elevated Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor:
China Medical University China
Organization:
China Medical University China
Study Overview
Official Title:
Anti-PD-1 Antibody Combined With Chemotherapy as First-line Treatment of Serum AFP-elevated Gastric or Gastroesophageal Junction Adenocarcinoma a Single-arm Multicenter Phase II Study
Status:
UNKNOWN
Status Verified Date:
2021-04
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:
The purpose of this study is to evaluate the efficacy and safety of of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma
Detailed Description:
AFP-elevated gastric adenocarcinoma is a special type of gastric cancer with the characteristics of high risk of liver and lymph node metastasis poor therapeutic effect and dismal prognosis
This prospective study is a single-arm multicenter phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma
AFP elevation is defined as serum AFP 20 ngml In this prospective study the objective remission rate ORR will be used as primary outcome measures and 30 patients will be recruited Anti-PD-1 antibody in combination with chemotherapy will be administered PD-L1 expression and tumor mutant burden TMB will be measured before treatment In addition the dynamic changes of serum AFP levels T lymphocyte in peripheral blood will be monitored during treatment In the course of treatment safety evaluation will be carried out according to the standard of adverse reaction classification CTCAE 40
This prospective study is a single-arm multicenter phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma
AFP elevation is defined as serum AFP 20 ngml In this prospective study the objective remission rate ORR will be used as primary outcome measures and 30 patients will be recruited Anti-PD-1 antibody in combination with chemotherapy will be administered PD-L1 expression and tumor mutant burden TMB will be measured before treatment In addition the dynamic changes of serum AFP levels T lymphocyte in peripheral blood will be monitored during treatment In the course of treatment safety evaluation will be carried out according to the standard of adverse reaction classification CTCAE 40
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