About this trial

This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.

Eligibility criteria

Qualifiers

Aged18-75 years, gender is not limited;

Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;

HER2-Positive (IHC3+or IHC2+/FISH+) ;

Has at least 1 measurable lesion as determined by RECIST 1.1;

Disqualifiers

Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;

Cardiovascular and cerebrovascular events that are not well controlled;

Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks.

Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);

Trial design

Treatments tested in this trial

  • Disitamab Vedotin
  • Sintilimab
  • S-1
  • Trastuzumab
  • Oxaliplatin
  • Capecitabine
  • 5-FU
  • Cisplatin

Treatment groups

110 Participants
are divided into 2 treatment groups

Locations

20
The First Affiliated Hospital of Zhengzhou University450052, ZhengzhouHenan, China
Binzhou Medical University Hospital BinzhouShandong, China
Shengli Oilfield Central Hospital DongyingShandong, China
Jinan Third People's Hospital JinanShandong, China

Sponsors and collaborators

Qilu Hospital of Shandong University

Lead sponsor