QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC/GEJ
Starting soon · Phase 3
Conditions studied: Gastric or Gastroesophageal Junction Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT07716449
- Run by
- Qilu Pharmaceutical Co., Ltd.
- People needed
- 560
- Starts
- 2026-08-01
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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