Viewing Study NCT04510064



Ignite Creation Date: 2024-05-06 @ 3:05 PM
Last Modification Date: 2024-10-26 @ 1:42 PM
Study NCT ID: NCT04510064
Status: UNKNOWN
Last Update Posted: 2020-08-12
First Post: 2020-08-10

Brief Title: PD-1 Antibody Combined With Modified FLOT Regimen in the Treatment of Unresectable Locally Advanced or Limited Metastatic Gastric Cancer
Sponsor: Fudan University
Organization: Fudan University

Study Overview

Official Title: Phase II Clinical Study of PD-1 Antibody Camrelizumab Combined With Modified FLOT Regimen in the Treatment of Unresectable Locally Advanced or Localized Metastatic Gastric Cancer
Status: UNKNOWN
Status Verified Date: 2020-08
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 study is to evaluate the efficacy and safety of domestic programmed death 1 PD-1 antibody Camrelizumab for injection combined with fluorouracil plus leucovorin oxaliplatin and albumin bound paclitaxel modified FLOT mFLOT regimen in the treatment of patients with unresectable locally advanced or limited metastatic gastric cancer The primary efficacy endpoint is R0 resection rate
Detailed Description: This is an open single center prospective phase II clinical study to evaluate the efficacy and safety of domestic PD1 antibody Camrelizumab for injection combined with mFLOT regimen in the treatment of unresectable locally advanced or limited metastatic gastric cancer This study will be carried out in our center about 40 patients will be enrolled

Patients with unresectable locally advanced or limited metastatic gastric cancer who had not received any prior antitumor therapies were treated with domestic PD1 antibody Caerelizumab for injection commbined with mFLOT regimen and human epidermal-growth-factor receptor 2 HER-2 positive patients were treated with Herceptin The efficacy of therapy was evaluated every 3 treatment cycles After 6 cycles surgical experts evaluated the resectability of the tumor and the patients who were confirmed to be resectable received surgery within 3-6 weeks after immunochemotherapy The patients with good postoperative recovery continued to receive the same immunochemotherapy in 3-6 weeks and totally at most 12 cycles Patients who were evaluated as progressive disease PD at any time withdrawn from the study as conversion failurePatients who did not PD at 6 cycles of treatment but did not reach the criteria for R0 resection continued to receive another 3 cycles of the prior chemotherapy If resectable then surgical treatment was performed if still unresectable the immunochemotherapy for transformation was evaluated as unsuccessful The patients were treated according to the principle of palliative treatment until the disease progressed or intolerable toxicity The efficacy and safety will be continuously monitored and evaluated throughout the study period including a 30 day follow-up period 40 cases were expected to be enrolled 3-4 cases per month completed in 1 year and finished in 2 years

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