Can some stomach cancer patients skip chemo after surgery?
NCT ID NCT07751302
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
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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
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2036
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The First Affiliated Hospital of Air Force Military Medical University
RECRUITINGXi'an, Shaanxi, 710032, China