NCT06155383

Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.

A Phase II Study of Perioperative Disitamab Vedotin Plus Toripalimab and XELOX Versus Disitamab Vedotin Plus Toripalimab Versus XELOX in Subjects With HER2-expressing Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Detailed description

This is an open-label, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing (immunohistochemical 1+, 2+, 3+) resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine	1000 mg/m2, Bid orally, D1-14, every 3 weeks
DRUG	oxaliplatin	130 mg/m2, intravenous infusion, D1, every 3 weeks
DRUG	Disitamab Vedotin	2.5 mg/kg, intravenous infusion, D1, every 2 weeks
DRUG	Toripalimab	3.0 mg/kg, intravenous infusion, D1, every 2 weeks

Timeline

• Start date: 2023-11-27
• Primary completion: 2025-01-31
• Completion: 2027-12-31
• First posted: 2023-12-04
• Last updated: 2023-12-14

Locations

11 sites across 1 country: China