Dual immunotherapy plus chemo before surgery: a new way to shrink stomach tumors?
NCT ID NCT07828873
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New triple therapy aims to shrink stomach tumors before surgery
- Immunotherapy duo aims to shrink stomach tumors before surgery
- Could blood pressure pills boost stomach cancer treatment?