QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC/GEJ | NCT07716449

NCT07716449

Overview

NCT ID: NCT07716449
Lead Sponsor: Qilu Pharmaceutical Co., Ltd.INDUSTRY
Official 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
Brief Summary: 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.
Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.