Dual immunotherapy plus chemo before surgery: a new way to shrink stomach tumors?

NCT ID NCT07828873

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether combining an experimental dual immunotherapy drug called QL1706 with standard chemotherapy (docetaxel, oxaliplatin and S-1) before surgery can help patients with locally advanced gastric or gastroesophageal junction cancer. The study enrolls 34 adults with previously untreated, resectable tumors. Participants receive 3 to 4 cycles of the combination, then those who are eligible undergo surgery to remove the tumor. The main goal is to measure how many patients have no remaining cancer cells in the removed tissue, a sign the treatment worked well.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iparomlimab and tuvonralimab (QL1706), an experimental dual immunotherapy, given with docetaxel, oxaliplatin and S-1 chemotherapy
What this could lead to
If it works, this approach could shrink tumors enough before surgery to improve outcomes for people with locally advanced stomach or gastroesophageal junction cancer.
What could go wrong
This is a small Phase 2 study with 34 patients and no comparison group, so any benefit is uncertain and may not hold up in larger trials. Immunotherapy plus chemotherapy can cause serious side effects, and some patients may not be able to complete treatment or reach surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 to 75 years; male or female. 2. Previously untreated, resectable adenocarcinoma of the stomach or gastroesophageal junction (GEJ). 3. Clinical stage cT3-4a/N+ M0. 4. ECOG performance status 0-1. 5. Adequate organ function within 7 days prior to treatment, meeting the following criteria: (1) Complete blood count (CBC) criteria (without blood transfusion within 14 days): Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 80 × 10⁹/L; (2) Serum chemistry criteria: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60 mL/min; (3) Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%). (4) Thyroid function: thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN). 6. Participants of childbearing potential must agree to use effective contraception during the study period and for 6 months after study completion. 7. The participant voluntarily agrees to participate in this study and signs the informed consent form. Exclusion Criteria: 1. Known history of hypersensitivity or allergy to QL1706 or its excipients, tegafur/gimeracil/oteracil (S-1), oxaliplatin, docetaxel, or any of their excipients. 2. History of another malignancy within 5 years prior to screening or concurrent malignancy, except for curatively treated carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors. 3. Patients with distant metastasis and/or unresectable disease; 4. Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, and anti-CTLA-4 agents. 5. Receipt of any antineoplastic agents within 4 weeks prior to the first dose of study drug. 6. Patients with gastrointestinal disorders such as intestinal obstruction (including partial obstruction), or those with evidence or risk of gastrointestinal bleeding, perforation, or obstruction. 7. Any bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to enrollment, or unhealed wounds, ulcers, or fractures. 8. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study. 9. Subjects requiring systemic therapy with corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of study drug. 10. Receipt of live or live-attenuated vaccine within 4 weeks prior to the first dose of study drug. 11. Major surgery or significant trauma within 4 weeks prior to the first dose of study drug. 12. Active or history of autoimmune disease, with the exception of vitiligo or resolved childhood asthma/atopy that requires no intervention in adulthood. 13. History of immunodeficiency, including HIV infection, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation. 14. Subjects with inadequately controlled cardiovascular clinical symptoms or diseases. 15. Severe infection (CTCAE Grade \> 2) within 4 weeks prior to the first dose of study drug. 16. Patients with a history of interstitial lung disease (except for radiation pneumonitis not treated with corticosteroids), non-infectious pneumonitis, or active pulmonary tuberculosis; or a history of active pulmonary tuberculosis within 1 year prior to enrollment, or more than 1 year prior to enrollment if not adequately treated. 17. Pregnant or breastfeeding women. 18. Other concomitant diseases that, in the opinion of the Investigator, pose a serious risk to the subject's safety or may interfere with the subject's ability to complete the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000, China

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