RecruitingPhase 2NCT06155383

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.


Sponsor

RemeGen Co., Ltd.

Enrollment

90 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of cancer treatments — including a targeted antibody-drug (disitamab vedotin), an immunotherapy drug (toripalimab), and standard chemotherapy — given before and after surgery for stomach or gastroesophageal junction cancer. The goal is to see if this combination can shrink the tumor before surgery and reduce the chance of the cancer coming back. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with stomach cancer or cancer at the junction of the stomach and esophagus - Your cancer has not spread to distant organs - Surgery to remove the cancer is planned and expected to be curative - You have not received any prior cancer treatment for this condition - Your HER2 protein levels show any level of expression (1+, 2+, or 3+) - Your heart, liver, kidney, and blood counts are within acceptable levels **You may NOT be eligible if...** - You have already received treatment for this cancer - Your cancer has spread to distant organs - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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

DRUGCapecitabine

1000 mg/m2, Bid orally, D1-14, every 3 weeks

DRUGoxaliplatin

130 mg/m2, intravenous infusion, D1, every 3 weeks

DRUGDisitamab Vedotin

2.5 mg/kg, intravenous infusion, D1, every 2 weeks

DRUGToripalimab

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

View Full Details on ClinicalTrials.gov

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NCT06155383


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