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Blood test could spare stomach cancer patients from unnecessary chemo

NCT ID NCT07508956

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a simple blood test that detects tiny bits of tumor DNA (ctDNA) can help doctors decide which stomach cancer patients need extra chemotherapy after surgery. About 304 people with locally advanced stomach cancer will be randomly assigned to either standard care or treatment guided by the blood test. The goal is to see if this approach can reduce unnecessary treatments and side effects while keeping survival rates just as good.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 304 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Mar 2032

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 years and older

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. Able to provide written informed consent (ICF) and capable of understanding and agreeing to comply with the study requirements and assessment schedule; 2. Male or female aged ≥ 18 years; 3. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, with clinical TNM stage (according to the 8th edition of the AJCC/UICC clinical TNM staging system for gastric cancer; see Appendix 1) of cIIB-IVA, and the primary gastric tumor assessed as amenable to radical resection; 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2), fit to undergo surgical treatment with no contraindications to surgery; 5. Capable of providing adequate tumor tissue obtained via gastroscopy (or other means) prior to neoadjuvant treatment for whole-exome sequencing; 6. Females of childbearing potential must have a negative pregnancy test within 7 days before initiation of neoadjuvant treatment. Males and females of childbearing potential must agree to use adequate contraception during the study period and for 24 months after the last dose of study treatment (see Appendix 3); 7. Hematologic and biochemical parameters meeting the following criteria prior to neoadjuvant treatment: * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L * Platelet count (PLT) ≥ 75 × 10⁹/L * Hemoglobin (Hb) ≥ 80 g/L * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) * Serum creatinine (Cr) ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m² * Serum albumin (ALB) ≥ 30 g/L * For subjects not receiving anticoagulant therapy: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; for subjects receiving anticoagulant therapy: PT within the expected therapeutic range for the anticoagulant; 8. No prior anticancer therapy for the current study-related tumor prior to initiation of neoadjuvant treatment. Exclusion Criteria: 1. Patients deemed by the investigator to have significant contraindications to or intolerance of neoadjuvant/adjuvant therapy; 2. Female patients of childbearing potential who have not undergone surgical sterilization or are not using adequate contraceptive measures, pregnant or lactating women, or male patients planning to father a child within a short period; 3. Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active hemorrhage, diabetes mellitus, etc.; 4. Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis, human immunodeficiency virus (HIV) infection, etc.; 5. Prior history of malignancy or current presence of another malignancy, except for completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast with at least 5 years without recurrence; 6. Other conditions deemed by the investigator to render the patient unsuitable for study participation.

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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

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032, China

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