A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.

Eligibility criteria

Qualifiers

Voluntarily consent to participate in the study and sign the informed consent form

Expected survival period >12 weeks

ECOG Performance Status 0 or 1

Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma

Disqualifiers

Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis

Peripheral neuropathy > Grade 1

Tumor lesions with a tendency to bleed

Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption

Trial design

Treatments tested in this trial

  • Disitamab Vedotin
  • Tislelizumab
  • CAPOX (oxaliplatin/capecitabine)
  • Trastuzumab
  • Pembrolizumab

Treatment groups

555 Participants
are divided into 2 treatment groups

Sponsors and collaborators