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Perioperative Chemotherapy Plus Trastuzumab Plus Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

NCT05715931 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-09-19

No results posted yet for this study

Summary

This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive locally advanced gastric or esophagogastric junction adenocarcinoma.

Conditions

  • Adenocarcinoma of the Stomach
  • Adenocarcinoma of Esophagogastric Junction
  • HER2-positive Gastric Cancer

Interventions

DRUG

Toripalimab

Toripalimab, 240 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery.

DRUG

Trastuzumab

Trastuzumab, 8 mg/kg IV loading dose at 1st administration and then 6 mg/kg IV on Day 1 of each 21 day cycle for 3 cycles before surgery and 3 cycles after surgery. The first administration of trastuzumab after surgery should also be given at the loading dose of 8 mg/kg.

DRUG

5-FU, leucovorin, docetaxel, oxaliplatin (FLOT)

Pre-operative treatment 4 cycles and post-operative treatment 4 cycles: Docetaxel 50 mg/m², IV on day 1 of each 14 day cycle; Oxaliplatin 85 mg/m² , IV on day 1 of each 14 day cycle; Leucovorin 200 mg/m² or Levoleucovorin 100 mg/m², IV on day 1 of each 14 day cycle; 5-FU 2600 mg/m², IV over 24 h on day 1 of each 14 day cycle.

Sponsors & Collaborators

  • Yu jiren

    lead OTHER

Principal Investigators

  • Jiren Yu · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2025-03-01
Completion
2028-03-01

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT05715931 on ClinicalTrials.gov