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PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma

NCT04341857 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-08-24

No results posted yet for this study

Summary

This is a prospective single arm phase II clinical study to compare the safety and efficacy of PD-1monoclonal antibody +FLOT in patients with gastric adenocarcinoma/esophagus-gastric junction adenocarcinoma.

Conditions

  • Gastric and Esophagogastric Junction Adenocarcinoma

Interventions

DRUG

PD-1 Monoclonal Antibody(Sintilimab)

Sintilimab combined with FLOT regimen,Docetaxel#50mg/m2d1,iv infusion for 1 hour#,Oxaliplatin#80mg/m2d1#iv infusion for 2 hours#,Calcium,leucovate#200mg/m2d1#iv infusion# ,Fluorouracil#2600mg/m2,intravenous drip for 24h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Ning Li, Phd · Henan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2022-05-30
Completion
2022-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04341857 on ClinicalTrials.gov