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

NCT06155383 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-12-14

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianmin Fang, Ph.D · RemeGen Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2025-01-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06155383 on ClinicalTrials.gov