Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University

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