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Stomach cancer hope: triple therapy may boost tumor clearance before surgery

NCT ID NCT07408609

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 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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase II trial tests whether adding low-dose radiotherapy and the immunotherapy drug tislelizumab to standard chemotherapy can improve outcomes for people with locally advanced stomach or gastroesophageal junction cancer. About 114 participants will be randomly assigned to receive either the combination therapy or chemotherapy alone before surgery. The main goal is to see if the combination leads to a higher rate of complete tumor disappearance (pathological complete response) at the time of surgery.

What this could mean

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

Active substance
tislelizumab (an immunotherapy drug), oxaliplatin, capecitabine, and low-dose radiation
What this could lead to
If successful, this combination could improve the chance of eliminating all visible cancer before surgery, potentially leading to better long-term outcomes for patients with locally advanced gastric cancer.
What could go wrong
This is a small, early-phase (phase II) trial, so results may not be definitive. Adding immunotherapy and radiation to chemotherapy may increase side effects, and the approach might not work better than chemotherapy alone.

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 114 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2031

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

20 to 80 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.Voluntary participation with written informed consent obtained; 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert type II/III) by endoscopic biopsy (pathology from outside institutions must be reviewed by the study center); 3. Staged as cT1-2N1-3M0 or cT3-4aN0-3M0 according to the AJCC 8th edition, based on endoscopy and imaging (CT, MRI, or PET-CT); 4. Age ≥20 and ≤80 years, male or female; ECOG performance status of 0-1; 5. Presence of measurable and/or non-measurable disease per RECIST v1.1; 6.No prior systemic antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational agents; Adequate organ function (no blood products or growth factors within 2 weeks prior to screening); 7. Women of childbearing potential must have a negative pregnancy test within 72 hours prior to first dosing and agree to use effective contraception during the study and for 5 months after the last dose; men with partners of childbearing potential must use effective contraception during the study and for 7 months after the last dose. Exclusion Criteria: 1. History of surgery for gastric or gastroesophageal junction tumors; 2. Prior history of fistula formation caused by invasion of the primary tumor; 3.High risk of gastrointestinal bleeding or perforation; 4.Poor nutritional status, defined as BMI \<18.5 kg/m² or PG-SGA score ≥9; 5. Major surgery or severe trauma within 4 weeks prior to first study drug administration; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Prior or ongoing treatment with anti-PD-1/PD-L1 antibodies, chemotherapy, radiotherapy, or targeted therapy; 7. Use of any investigational drug within 4 weeks prior to first study drug administration; Requirement for systemic corticosteroids; 8. Prior receipt of antitumor vaccines or live vaccines within 4 weeks before first study drug administration; 9. Active autoimmune disease or history of autoimmune disease; 10.History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, solid organ transplantation, or allogeneic bone marrow transplantation; 11.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 12.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 13.Severe infection (CTCAE grade \>2) within 4 weeks prior to treatment, including infections requiring hospitalization; evidence of active pulmonary infection at baseline imaging or infections requiring antibiotics within 2 weeks prior to enrollment (prophylactic antibiotics excluded); 14.History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 15.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 16.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 17.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 18.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 19.Severe infection (CTCAE grade \>2) within 4 weeks prior to treatment; History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 20.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 21.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 22.Grade \>1 abnormalities in serum sodium, potassium, or calcium within 2 weeks prior to enrollment that cannot be corrected with treatment.

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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 official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

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