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RECRUITING
NCT06155383
PHASE2

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

Sponsor: RemeGen Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-11-27

Completion Date

2027-12-31

Last Updated

2023-12-14

Healthy Volunteers

No

Interventions

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

Locations (11)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Yunnan Cancer Hospital

Kunming, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Shandong Cancer Hospital & Institute

Jinan, Shangdong, China

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, China