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

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 28, 2023

Primary Completion Date

March 1, 2025

Study Completion Date

March 1, 2028

Conditions
Adenocarcinoma of the StomachAdenocarcinoma of Esophagogastric JunctionHER2-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."

Trial Locations (8)

310003

RECRUITING

The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou

NOT_YET_RECRUITING

The Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou

313099

NOT_YET_RECRUITING

Huzhou Central Hospital, Huzhou

315010

NOT_YET_RECRUITING

Ningbo First Hospital, Ningbo

315048

NOT_YET_RECRUITING

Ningbo Medical Center LiHuiLi Hospital, Ningbo

315099

NOT_YET_RECRUITING

Ningbo Second Hospital, Ningbo

317099

NOT_YET_RECRUITING

Taizhou Hospital, Taizhou

323000

NOT_YET_RECRUITING

Lishui Central Hospital, Lishui

All Listed Sponsors
lead

Yu jiren

OTHER