Can a new immunotherapy combo make stomach tumors disappear before surgery?

NCT ID NCT07776639

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Started

May 2026

Expected to finish

Sep 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: * 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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