Can a new immunotherapy combo make stomach tumors disappear before surgery?
NCT ID NCT07776639
First seen Aug 20, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This trial is testing whether adding an experimental immunotherapy (QL1706) to a standard chemotherapy regimen (DOS) before surgery can help people with locally advanced stomach or gastroesophageal junction cancer. The goal is to see if the combination can completely eliminate the tumor before surgery, improving the chances of a successful operation. About 34 adults with untreated, operable cancer will receive the treatment for 3-4 cycles, then undergo surgery to evaluate the results.
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) combined with docetaxel, oxaliplatin, and S-1 (DOS regimen)
- What this could lead to
- If successful, this combination could increase the chance of complete tumor removal and improve long-term outcomes for people with locally advanced stomach cancer.
- What could go wrong
- This is a small, early-phase study, so results may not apply broadly. The combination may cause significant side effects, and the added benefit over standard chemotherapy is not yet proven.
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.
- Started
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May 2026
- Expected to finish
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Sep 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: * Aged 18-75 years old, male or female; * Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction; * Clinical stage cT3-4a/N+M0; * ECOG performance status 0-1; * Adequate function of major organs assessed within 7 days before treatment: 1. Hematological indicators (without blood transfusion within 14 days): Hemoglobin (HB) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet (PLT) ≥80×10⁹/L; 2. Biochemical indicators: 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. Assessed by Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%); 4. Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; * Subjects of childbearing potential agree to use effective contraception during the study and for 6 months after the end of study treatment; * Subjects voluntarily participate in this study and sign written informed consent. Exclusion Criteria: * Inclusion Criteria: * Aged 18-75 years old, male or female; * Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction; * Clinical stage cT3-4a/N+M0; * ECOG performance status 0-1; * Adequate function of major organs assessed within 7 days before treatment: 1. Hematological indicators (without blood transfusion within 14 days): Hemoglobin (HB) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet (PLT) ≥80×10⁹/L; 2. Biochemical indicators: 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. Assessed by Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%); 4. Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; * Subjects of childbearing potential agree to use effective contraception during the study and for 6 months after the end of study treatment; * Subjects voluntarily participate in this study and sign written informed consent. Exclusion Criteria: * History of hypersensitivity to any component of QL1706, tegafur-gimeracil-oteracil potassium, oxaliplatin, docetaxel, or any of their excipients; * History of other malignant tumors within the past 5 years or concurrent other malignant tumors, except cured carcinoma in situ of cervix, non-melanoma skin cancer, and superficial bladder tumors; * Patients with distant metastasis or unresectable disease; * Prior receipt of immunotherapy (anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.); * Received any anti-tumor agents within 4 weeks prior to the first study drug administration; * Patients with intestinal obstruction (including incomplete intestinal obstruction) or other gastrointestinal diseases that may lead to gastrointestinal hemorrhage, perforation or obstruction; * Patients with any bleeding event ≥ CTCAE Grade 3, unhealed wounds, ulcers or fractures within 4 weeks before screening; * Concurrent enrollment in another interventional clinical trial, except observational (non-interventional) clinical trials or follow-up phase of interventional trials; * Subjects requiring systemic treatment with corticosteroids (\>10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks before the first study drug administration; * Received live vaccines within 4 weeks prior to the first study drug administration; * Underwent major surgery or suffered trauma within 4 weeks before the first study drug administration; * Active autoimmune disease or history of autoimmune disease, except vitiligo or childhood asthma/allergy that has resolved and requires no intervention in adulthood; * History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation; * Subjects with inadequately controlled cardiovascular clinical symptoms or diseases; * Severe infection (CTCAE Grade \> 2) occurring within 4 weeks prior to the first study drug administration; * History of interstitial lung disease (except radiation pneumonia without corticosteroid treatment), non-infectious pneumonia, active pulmonary tuberculosis infection; patients with history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with history of active pulmonary tuberculosis infection more than 1 year ago without standardized treatment; * Pregnant or breastfeeding women; * Other concomitant diseases that, in the investigator's opinion, may seriously endanger the subject's safety or prevent the subject from completing 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.
Contacts and locations
Locations
-
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
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