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Can some stomach cancer patients skip chemo after surgery?

NCT ID NCT07751302

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial is testing whether close follow-up is as good as adjuvant chemotherapy for patients with early-stage (IB-IIA) stomach or gastroesophageal junction cancer after curative surgery. Patients are divided into low-risk and high-risk groups based on factors like lymph node involvement. High-risk patients are randomly assigned to either close monitoring or chemotherapy with an oral drug. The goal is to see which approach better prevents cancer recurrence and improves survival.

What this could mean

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

Active substance
Tegafur Gimeracil Oteracil Potassium Capsules (an oral chemotherapy drug)
What this could lead to
If successful, this could show that some patients with early-stage stomach cancer can safely skip chemotherapy and just be closely monitored, reducing treatment burden while maintaining similar outcomes.
What could go wrong
The trial is early and may not show a clear benefit for either approach. Chemotherapy can cause side effects, and close follow-up might miss early recurrence in some patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2036

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.Aged ≥18 years of either gender. 2.Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with an ECOG performance status score ≤2. 3.Pathologic TNM stage IB-IIA gastric or gastroesophageal junction adenocarcinoma, excluding T2N1. 4.Curative surgical resection of the primary tumor completed. 5.Laboratory test criteria as below: 1. Absolute neutrophil count (ANC) ≥1.5×10⁹/L without granulocyte colony-stimulating factor administration within the preceding 14 days; 2. Platelet count ≥100×10⁹/L without blood transfusion within the preceding 14 days; 3. Hemoglobin \>9 g/dL without blood transfusion or erythropoietin administration within the preceding 14 days; 4. Total bilirubin ≤1.5×upper limit of normal (ULN); 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; 6. Serum creatinine ≤1.5×ULN and calculated creatinine clearance (Cockcroft-Gault formula) ≥60 mL/min; 7. Adequate coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; 8. Cardiac biomarkers within normal range; isolated laboratory abnormalities deemed clinically insignificant by the investigator are acceptable. 6.Voluntary participation and written informed consent obtained prior to study enrollment Exclusion Criteria: * 1\. Other malignant tumors of the stomach. 2. Receipt of any anti-tumor therapy other than the chemotherapy specified in this protocol prior to screening or planned administration of such therapy during the trial (including radiotherapy, targeted therapy, immunotherapy, etc.). 3\. Concurrent or prior malignancy at other anatomic sites, except for adequately treated carcinoma in situ of cervix, basal cell carcinoma of skin, or other malignancies surgically cured with no disease recurrence for at least 5 years. 4\. Presence of any severe or uncontrolled systemic diseases as follows: 1. Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA Grade ≥Ⅱ. 2. Resting electrocardiogram showing severe, symptomatic and refractory abnormalities in cardiac rhythm, conduction or morphology, including complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia or atrial fibrillation. 3. History of arterial thrombosis, embolism or ischemic events within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack. 4. Poorly controlled hypertension (systolic BP\>140 mmHg, diastolic BP\>90 mmHg). 5. History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year prior to first study drug administration, or clinically active interstitial lung disease at screening. 6. Active pulmonary tuberculosis. 7. Active or uncontrolled infection requiring systemic treatment. 8. Clinically active diverticulitis, intra-abdominal abscess or gastrointestinal obstruction. 9. Hepatic diseases including liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis. 10. Poorly controlled diabetes mellitus (fasting blood glucose, FBG\>10 mmol/L). 11. Urinalysis showing ≥2+ proteinuria confirmed by 24-hour urinary protein quantification\>1.0 g. 12. Psychiatric disorders rendering the subject unable to comply with study treatment. 5\. Current participation in another clinical trial or participation in any other clinical trial within the preceding 3 months. 6\. Known hypersensitivity to any investigational drugs used in this study. 7. Subjects deemed ineligible for enrollment at the Investigator's discretion.

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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 First Affiliated Hospital of Air Force Military Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China