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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07716449

Enrollment

560

Registered

2026-07-21

Start date

2026-08-01

Completion date

2029-08-01

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGQLS31905

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

DRUGSintilimab

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

DRUGOxaliplatin

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

DRUGCapecitabine

Capecitabine will be administered orally twice daily (bid).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Progression free survival (PFS)	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).

Contacts

CONTACTLin Shen, PhD

doctorshenlin@sina.cn010-88196358

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026