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

NCT07716449 | Not Yet Recruiting Phase 3

• 1 other identifier: QLS31905-302
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  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).

  Up to 44 months

Study Arms (2)

QLS31905+Oxaliplatin+Capecitabine

EXPERIMENTAL

Drug: QLS31905; Drug: Oxaliplatin; Drug: Capecitabine

Sintilimab+Oxaliplatin+Capecitabine

ACTIVE COMPARATOR

Drug: Sintilimab; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Sintilimab DRUG

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

Sintilimab+Oxaliplatin+Capecitabine

Oxaliplatin DRUG

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

QLS31905+Oxaliplatin+Capecitabine; Sintilimab+Oxaliplatin+Capecitabine

Capecitabine DRUG

Capecitabine will be administered orally twice daily (bid).

QLS31905+Oxaliplatin+Capecitabine; Sintilimab+Oxaliplatin+Capecitabine

QLS31905 DRUG

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

QLS31905+Oxaliplatin+Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

sintilimab; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Lin Shen, PhD

CONTACT

010-88196358; doctorshenlin@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 21, 2026

Record last verified: 2026-05