A Randomized, Controlled, Open-Label, Multi-center Clinical Study Comparing the Efficacy of Close… (NCT07751302) | Clinical Trial Compass
RecruitingNot Applicable
A Randomized, Controlled, Open-Label, Multi-center Clinical Study Comparing the Efficacy of Close Follow-Up Versus Adjuvant Chemotherapy in Patients With Stage IB-IIA Gastric or Gastroesophageal Junction Adenocarcinoma Following Radical Surgery
China500 participantsStarted 2026-08-10
Plain-language summary
This study is a randomized, controlled, open-label, multicenter trial. Patients who underwent radical resection for stage IB-IIA gastric or gastroesophageal junction adenocarcinoma were enrolled and stratified into low-risk and high-risk groups based on the presence of lymph node metastasis, vascular invasion, or elevated preoperative tumor markers (CEA or CA19-9). Patients in the low-risk group were directly enrolled in follow-up observation, while those in the high-risk group were randomized 1:1 to either close follow-up or adjuvant chemotherapy. The primary endpoint of the study is the efficacy and safety of adjuvant chemotherapy following radical resection in patients with stage IB-IIA gastric or gastroesophageal junction adenocarcinoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
.Curative surgical resection of the primary tumor completed. 5.Laboratory test criteria as below:
. Absolute neutrophil count (ANC) ≥1.5×10⁹/L without granulocyte colony-stimulating factor administration within the preceding 14 days;
. Platelet count ≥100×10⁹/L without blood transfusion within the preceding 14 days;
. Hemoglobin \>9 g/dL without blood transfusion or erythropoietin administration within the preceding 14 days;
. Total bilirubin ≤1.5×upper limit of normal (ULN);
. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease-Free Survival (DFS) difference among three study arms after curative resection for stage IB-IIA gastric/gastroesophageal junction adenocarcinoma
Timeframe: From randomization until 5 years after the last enrolled subject completes follow-up (median follow-up duration ≥36 months)
. Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA Grade ≥Ⅱ.
. 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.
. 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.
. 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.
. Active pulmonary tuberculosis.
. Active or uncontrolled infection requiring systemic treatment.
. Clinically active diverticulitis, intra-abdominal abscess or gastrointestinal obstruction.