RecruitingPhase 2NCT05715931

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

Sponsor

Yu jiren

Enrollment

30 participants

Start Date

Feb 28, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy, the targeted drug trastuzumab (Herceptin), and the immunotherapy drug toripalimab given before and after surgery for patients with HER2-positive stomach or gastroesophageal junction cancer. The goal is to shrink the tumor before surgery and prevent it from coming back afterward. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with stomach or gastroesophageal junction adenocarcinoma that tests strongly positive for the HER2 protein - Your cancer is locally advanced (stage T2 or higher, or with lymph node involvement) but has not spread to distant organs - You are in good general health and able to tolerate treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have significant heart, liver, or kidney problems preventing you from tolerating treatment - You are pregnant or breastfeeding - You have received prior cancer treatment for this diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

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

DRUGTrastuzumab

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.

DRUG5-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.