Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRemeGen Co., Ltd.
About this trial
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 criteria
Qualifiers
Voluntarily participate and sign the informed consent form;
Male or female, ≥18 years;
Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology;
Clinical stage cT3-4aN+, no distant metastasis (M0);
Disqualifiers
Received any anti-tumor therapy for gastric or gastroesophageal junction adenocarcinoma before study dosing, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and other anti-tumor drug therapy (including Chinese medicine treatment with anti-tumor ingredients specified in the instructions within 2 weeks before screening);
The investigators considered perioperative period treatment of patients requiring radiotherapy for target lesions；
Major surgery was performed within 4 weeks before the start of study dosing and did not fully recover;
Patients with active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening;
Trial design
Treatments tested in this trial
- Capecitabine
- oxaliplatin
- Disitamab Vedotin
- Toripalimab
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov