QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC/GEJ
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS31905, Sintilimab, Oxaliplatin, Capecitabine.
- Who it may be relevant to
- Registry conditions: Gastric or Gastroesophageal Junction Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug QLS31905
QLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle. - Drug Sintilimab
Sintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle. - Drug Oxaliplatin
Oxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle. - Drug Capecitabine
Capecitabine will be administered orally twice daily (bid).
Primary outcome measures
- Progression free survival (PFS) [Time frame: Up to 44 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07716449 · QLS31905-302