NCT05715931

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

A Multi-center, Phase II Study to Evaluate Efficacy and Safety of Perioperative Chemotherapy With Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel (FLOT) and Trastuzumab in Combination With Toripalimab in Patients With HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yu jiren · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-02-28
• Primary completion: 2025-03-01
• Completion: 2028-03-01
• First posted: 2023-02-08
• Last updated: 2024-09-19

Locations

8 sites across 1 country: China