Gastric or Gastroesophageal Junction AdenocarcinomaPhase 3NCT07716449
QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC/GEJ
A Phase 3 study testing QLS31905, Sintilimab and Oxaliplatin in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 , Her-2 Negtive unresectable locally advanced or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- QLS31905, Sintilimab and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2026to Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Lin Shen, PhD, 010-881965671, linshenpku@163.com
About this study
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 ，Her-2 Negtive Gastric or Gastroesophageal Junction Adenocarcinoma
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.
- Being tested
- QLS31905, Sintilimab, Oxaliplatin, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS31905Drug
QLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
SintilimabDrug
Sintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
OxaliplatinDrug
Oxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
CapecitabineDrug
Capecitabine will be administered orally twice daily (bid).
| Study group | Role | What they receive |
|---|---|---|
| QLS31905+Oxaliplatin+Capecitabine | Experimental | Not described Receives: Drug: QLS31905; Drug: Oxaliplatin; Drug: Capecitabine |
| Sintilimab+Oxaliplatin+Capecitabine | Active comparator | Not described Receives: Drug: Sintilimab; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall Survival
Measured: Up to 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start24 Sep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716449
- Sponsor's protocol ID
- QLS31905-302
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ，Her-2 Negtive Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07716449
- Acronym / sponsor ID
- QLS31905-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLS31905+Oxaliplatin+Capecitabine | Experimental | Drug: QLS31905, Drug: Oxaliplatin, Drug: Capecitabine |
| Sintilimab+Oxaliplatin+Capecitabine | Active comparator | Drug: Sintilimab, Drug: Oxaliplatin, Drug: Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLS31905QLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle. | Drug | QLS31905+Oxaliplatin+Capecitabine |
| SintilimabSintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle. | Drug | Sintilimab+Oxaliplatin+Capecitabine |
| OxaliplatinOxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle. | Drug | QLS31905+Oxaliplatin+Capecitabine, Sintilimab+Oxaliplatin+Capecitabine |
| CapecitabineCapecitabine will be administered orally twice daily (bid). | Drug | QLS31905+Oxaliplatin+Capecitabine, Sintilimab+Oxaliplatin+Capecitabine |
Primary outcome
OS
Time frame: Up to 44 months
Overall Survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QLS31905, Sintilimab and Oxaliplatin in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, PhD (010-88196358, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: Up to 44 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.