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NCT Number: NCT07716449

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

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 unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

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Key information

Conditions

Gastric or Gastroesophageal Junction Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ≥ 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;
  • At least one measurable lesion per RECIST v1.1;
  • 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.

Treatment and study plan

QLS31905

Drug

QLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.

Sintilimab

Drug

Sintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.

Oxaliplatin

Drug

Oxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.

Capecitabine

Drug

Capecitabine will be administered orally twice daily (bid).

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: Up to 44 months

    PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease by Blinded Independent Central Review (BICR) evaluation or death due to any cause (whichever occurs first).

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Shen, PhD

CONTACT

[email protected]

010-88196358

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Multicenter Phase III Clinical Study of QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic CLDN18.2-positive, PD-L1 CPS < 5 Gastric or Gastroesophageal Junction Adenocarcinoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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