Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05221775
Status:
UNKNOWN
Last Update Posted:
2022-02-03
First Post:
2022-01-23
Brief Title:
Safety of XELOX Combined With GLS-010 and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Safety and Efficacy of XELOX Regimen Combined With GLS-010 and Lenvatinib in Patients With Advanced AFP-positive Gastric Cancer a Single Center Prospective Open Label Phase I Study
Status:
UNKNOWN
Status Verified Date:
2022-01
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 prospective open label phase I study evaluating the safety and tolerance of standard first-line chemotherapy XELOX regimen combined with GLS-010 anti-PD-1 antibody and different doses of Lenvatinib in the treatment of advanced AFP-positive gastric cancer This study was conducted in the Department of Gastrointestinal Medical Oncology Tianjin Medical University Cancer Institute and Hospital In this study patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled Patients who met the inclusion criteria were treated with XELOX regimen combined with GLS-010 plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death The treatment regimen is XELOX chemotherapy oxaliplatin 130mg m2 d1 capecitabine 850-1250 mgm2 bid d1-14 every 3 weeks in combination with GLS-010 240 mg intravenous infusion every 3 weeks plus Lenvatinib whose dose is based on the 3 3 dose climbing mode 12mg 16mg and 20mg respectively orally once a day Safety will be evaluated by AE and laboratory tests Patients received regular and periodic reviews with imaging evaluations every 6 weeks
Detailed Description:
None
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