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โ† Trials
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QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC/GEJ

RecruitingPhase 3Ages 18 Years - anyAllQilu Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

This study is a randomized, open, multicenter phase III clinical study designed to compare the efficacy and safety of QLS31905 injection combined with CAPOX versus sintilimab combined with CAPOX in the first-line treatment of CLDN18.2 positive, PD-L1 CPS \< 5 , Her-2 Negtive unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Subjects voluntarily participate in the study and sign the informed consent form; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; * Expected survival time โ‰ฅ 12 weeks; * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma; * No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease; * Has measurable or non-measurable (but assessable) disease; * Patients with adequate cardiac, liver, renal function, etc. Exclusion Criteria: * Known history of allergy to any component of the study drug; * Other second primary malignant neoplasm within 5 years; * Significant cardiovascular and cerebrovascular disorders within 6 months before randomization; * Haemorrhage requiring haemostatic treatment within 3 months prior to randomisation; * Previous or current interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, etc; * Previous treatment targeting CLDN18.2; * Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.
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What it tests

  • QLS31905
  • Sintilimab
  • Oxaliplatin
  • Capecitabine
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Where

1 site
Beijing Cancer Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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