About this trial

This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma

Eligibility criteria

Qualifiers

Aged 18-75 years, gender is not limited;

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

HER2-negative by immunohistochemistry (IHC);

low PD-L1 expression status (CPS < 5);

Disqualifiers

Allergic 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

  • Iparomlimab and Tuvonralimab (QL1706)
  • Oxallplation
  • Capectitabine Tablets

Treatment groups

77 Participants
are divided into 1 treatment group

Locations

29
The First Affiliated Hospital of Zhengzhou University450052, ZhengzhouHenan, China
Binzhou Medical University Hospital BinzhouShandong, China
Dezhou People's Hospital DezhouShandong, China
Shengli Oilfield Central Hospital DongyingShandong, China

Sponsors and collaborators

Qilu Hospital of Shandong University

Lead sponsor