NCT07716449RecruitingPhase 3
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 ，Her-2 Negtive Gastric or Gastroesophageal Junction Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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 , Her-2 Negtive unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 560 (estimated)
- First submitted
- 16 Jul 2026
- Start date
- 24 Sept 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07716449
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 560
- From 24 Sept 2026 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Known history of allergy to any component of the study drug;
- Other second primary malignant neoplasm within 5 years;
Other
- 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.
Who the study is looking for
- 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;
- Has measurable or non-measurable (but assessable) disease;
- Patients with adequate cardiac, liver, renal function, etc.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.