Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04006821
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2019-07-01
Brief Title:
PD-1 Antibody Apatinib Mesylate in 2 Line Serum AFP-elevated Gastric Adenocarcinoma
Sponsor:
China Medical University China
Organization:
China Medical University China
Study Overview
Official Title:
PD-1 Antibody Combined With Apatinib Mesylate as 2 Line Treatment of Serum AFP-elevated Gastric Adenocarcinoma an Open-label Single-arm Multicenter Phase II Study
Status:
UNKNOWN
Status Verified Date:
2021-09
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 PD-1 antibody combined with apatinib mesylate in patients with unresectable local advanced recurrent or metastatic serum AFP-elevated gastric adenocarcinoma who have at least received first-line antitumor therapy or whose standard treatment is intolerable
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 prognosis
This prospective study is a single-arm open-label multi-center phase II clinical trial to evaluate the efficacy and safety of PD-1 antibody combined with apatinib mesylate in patients with unresectable local advanced recurrent or metastatic serum AFP-elevated gastric adenocarcinoma who have at least received first-line antitumor therapy or whose standard treatment is intolerable
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 PD-1 antibody combined with apatinib mesylate will be administered PD-L1 expression and TMB will be measured before treatment In addition the dynamic changes of serum AFP levels T lymphocyte in peripheral blood will be monitored before each treatment cycle 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 open-label multi-center phase II clinical trial to evaluate the efficacy and safety of PD-1 antibody combined with apatinib mesylate in patients with unresectable local advanced recurrent or metastatic serum AFP-elevated gastric adenocarcinoma who have at least received first-line antitumor therapy or whose standard treatment is intolerable
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 PD-1 antibody combined with apatinib mesylate will be administered PD-L1 expression and TMB will be measured before treatment In addition the dynamic changes of serum AFP levels T lymphocyte in peripheral blood will be monitored before each treatment cycle 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