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Stomach cancer trial combines chemo with Bacteria-Fighting treatment

NCT ID NCT06510010

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study is for people with a type of stomach cancer that is H. pylori-positive and can be removed with surgery. It compares standard chemotherapy before and after surgery to the same chemotherapy plus treatment to eliminate H. pylori bacteria. The goal is to see if adding the bacteria treatment helps shrink the tumor more before surgery. About 180 adults will take part.

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 198 people

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

Started

Dec 2024

Expected to finish

Jul 2027

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. have been fully informed about the study and voluntarily signed the informed consent form (ICF); 2. Gastroscopy pathology confirmed locally advanced adenocarcinoma of the gastric and oesophagogastric junction (Siewert type I-III); 3. Clinical (enhanced CT, enhanced MRI, or PET-CT) staging at the time of diagnosis: cT3/4a Nx or T2 N2/3, M0 (The American Joint Committee on Cancer 8th edition): 4. The present H. Pylori infection at the time of diagnosis is determined by one of the following 3 items: ① Positive gastric mucosal tissue rapid urease test (RUT), tissue section staining, or bacterial culture for any of the 3 items. Positive 13C or 14C-urea breath test (UBT). ③ Positive helicobacter pylori stool antigen (HpSA) tests (clinically validated monoclonal antibody method). Positive serum H. Pylori antibody test (clinically proven reagent with high accuracy) suggests previous infection, and those who have never been treated can be considered as having current infection; 5. Sex is not limited and age is 18-75 years old; 6. Eastern Cooperative Oncology Group (ECOG) score 0-1; 7. Organ function permits major abdominal surgery; 8. Expected survival ≥ 6 months; 9. Laboratory test values must meet the following criteria within 7 days prior to enrollment: 1. whole-body cryotherapy/cryostimulation (WBC) \> 4.0 × 10\^9/L and \< 15 × 10\^9/L, ANC \> 1.5 × 10\^9/L, Hb ≥ 75 g/L, PLT ≥ 100 × 10\^9/L; 2. Serum bilirubin ≤ 1.5 x high limit of normal, aspartate transaminase (AST), alanine aminotransferase (ALT) ≤ 2.5 x high limit of normal; 3. Creatinine ≤ 1.5 x high limit of normal or creatinine clearance rate \> 60 ml/min; 4. international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × Upper limit of normal ( ULN ) only for subjects not receiving anticoagulation; subjects receiving anticoagulation should be on a stable dose; 10. Ability to cooperate with the appropriate endoscopic, laboratory and imaging tests for this protocol; 11. Females of childbearing potential (including females who are menopausal due to chemo-menopause or other medical reasons) must agree to use contraception for a period of at least 6 months from the time of signing the Informed Consent Form to at least 6 months after the last dose of study treatment or concomitant chemotherapy, whichever is later. Females must also agree to refrain from breastfeeding for a period of at least 6 months from the time of signing the informed consent to the time of the last administration of the study drug or concomitant chemotherapy, whichever is later; males must agree to use contraception for a period of at least 6 months from the time of administration of the test drug to the time of the last administration of the test drug or concomitant chemotherapy, whichever is later. Exclusion Criteria: 1. Stage IV or unresectable gastric or gastroesophageal junction cancer as determined by the investigator; 2. Other active malignancies within 5 years or concurrently. 3. Patients who are preparing for or have previously received organ or bone marrow transplantation; 4. Myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women) within 6 months prior to the first dose (QTc interval is calculated by the Fridericia formula); 5. Presence of New York Heart Association (NYHA) class III-IV cardiac insufficiency or cardiac ultrasound: LVEF (left ventricular ejection fraction) \< 50%; 6. Presence of active pulmonary tuberculosis by history or CT, or patients with a history of active pulmonary tuberculosis within 1 year prior to enrollment, or patients with a history of active pulmonary tuberculosis more than 1 year prior but without regular treatment; 7. Presence of a known active or suspected autoimmune disease. The exception is those who are in a stable state of that disease at the time of enrollment (not requiring systemic immunosuppression therapy); 8. Received a live vaccine within 28 days prior to the first dose; except inactivated viral vaccines for seasonal influenza; 9. Patients requiring treatment with systemic corticosteroids (\> 10 mg/day prednisone efficacy dose) or other immunosuppressive drugs within 14 days prior to first dose or during the study period. However, enrollment is permitted if patients are allowed to be treated with topical topical or inhaled steroids, or adrenal hormone replacement therapy at doses ≤ 10 mg/day prednisone efficacy dose in the absence of active autoimmune disease; 10. Undergoing treatment in another clinical study or scheduled to begin treatment in this study less than 14 days from the end of treatment in the previous clinical study; 11. Known history of severe allergy to any study drug excipients; 12. known history of psychotropic pharmaceuticals abuse or drug addiction; patients who have stopped drinking alcohol can be enrolled; 13. Presence of patients with conditions that may increase the risk of study medication, or other severe, acute and chronic medical conditions that, in the judgment of the investigator, make participation in a clinical study unsuitable.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Sixth Affiliated Hospital,Sun Yat-sen University

    RECRUITING

    Guangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.