Stage IB-IIA Adenocarcinoma of the Stomach or Gastroesophageal JunctionNCT07751302
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
A study testing Tegafur Gimeracil Oteracil Potassium Capsules for oral administration in people with Stage IB-IIA Adenocarcinoma of the Stomach or Gastroesophageal Junction, run by Xijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IB-IIA Adenocarcinoma of the Stomach or Gastroesophageal Junction
- What is being tested?
- Tegafur Gimeracil Oteracil Potassium Capsules for oral administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to 31 Jan 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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;
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- Total bilirubin ≤1.5×upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;
- Serum creatinine ≤1.5×ULN and calculated creatinine clearance (Cockcroft-Gault formula) ≥60 mL/min;
- Adequate coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;
- 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
Who cannot join
- 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:
- 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.
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- Poorly controlled hypertension (systolic BP>140 mmHg, diastolic BP>90 mmHg).
- 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.
- Hepatic diseases including liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
- Poorly controlled diabetes mellitus (fasting blood glucose, FBG>10 mmol/L).
- Urinalysis showing ≥2+ proteinuria confirmed by 24-hour urinary protein quantification>1.0 g.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032
Yongzhan Nie, +86 198 2975 8242, zhengrong4956@163.com
About this study
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.
- Being tested
- Tegafur Gimeracil Oteracil Potassium Capsules for oral administration
- Keywords
- Stage IB-IIA adenocarcinoma of the stomach or gastroesophageal junction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegafur Gimeracil Oteracil Potassium Capsules for oral administrationDrug
Tegafur Gimeracil Oteracil Potassium Capsules for oral administration, dosage regimen:Body surface area (BSA) <1.25 m²: 40 mg per dose, twice daily; 1.25 m² ≤ BSA <1.5 m²: 50 mg per dose, twice daily; BSA ≥1.5 m²: 60 mg per dose, twice daily. Medication is administered consecutively for 14 days followed by a 7-day drug-free interval to complete one treatment cycle, with a total of 8 cycles planned.
| Study group | Role | What they receive |
|---|---|---|
| Low-risk follow-up group (Control Group 1) | No intervention | Patients receive follow-up only. |
| High-risk close follow-up group (Control Group 2) | No intervention | High-risk close follow-up group (Control Group 2): Patients receive follow-up only. |
| High-risk adjuvant chemotherapy group (Experimental Group) | Active comparator | High-risk adjuvant chemotherapy group (Experimental Group): Oral administration of Tegafur Gimeracil Oteracil Potassium Capsules. Dosage:
Body surface area < 1.25 m²: 40 mg twice daily 1.25 m² ≤ Body surface area < 1.5 m²: 50 mg twice daily Body surface area ≥ 1.5 m²: 60 mg twice daily One treatment cycle consists of 14 consecutive days of medication followed by a 7-day drug holiday, for a total of 8 cycles. Receives: Drug: Tegafur Gimeracil Oteracil Potassium Capsules for oral administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS) difference among three study arms after curative resection for stage IB-IIA gastric/gastroesophageal junction adenocarcinoma
Measured: From randomization until 5 years after the last enrolled subject completes follow-up (median follow-up duration ≥36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion31 Jan 2036 (estimated)
- Study completion31 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IB-IIA Adenocarcinoma of the Stomach or Gastroesophageal JunctionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751302
- Sponsor's protocol ID
- KY20262031-C-1
- Status last verified
- Jan 2026
- First submitted
- 8 Jun 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Applications for data access shall be submitted to the study principal investigator upon completion of the study. The applicant is required to provide a data analysis plan, and data sharing will be approved following institutional review and assessment.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07751302
- Acronym / sponsor ID
- KY20262031-C-1
- Keywords
- Stage IB-IIA adenocarcinoma of the stomach or gastroesophageal junction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2036 (estimated)
- Study completion
- 31 Jan 2036 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-risk follow-up group (Control Group 1) | No intervention | –Patients receive follow-up only. |
| High-risk close follow-up group (Control Group 2) | No intervention | –High-risk close follow-up group (Control Group 2): Patients receive follow-up only. |
| High-risk adjuvant chemotherapy group (Experimental Group) | Active comparator | Drug: Tegafur Gimeracil Oteracil Potassium Capsules for oral administrationHigh-risk adjuvant chemotherapy group (Experimental Group): Oral administration of Tegafur Gimeracil Oteracil Potassium Capsules. Dosage: Body surface area < 1.25 m²: 40 mg twice daily 1.25 m² ≤ Body surface area < 1.5 m²: 50 mg twice daily Body surface area ≥ 1.5 m²: 60 mg twice daily One treatment cycle consists of 14 consecutive days of medication followed by a 7-day drug holiday, for a total of 8 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 6.Voluntary participation and written informed consent obtained prior to study enrollment
Key exclusion criteria (17 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tegafur Gimeracil Oteracil Potassium Capsules for oral administrationTegafur Gimeracil Oteracil Potassium Capsules for oral administration, dosage regimen:Body surface area (BSA) <1.25 m²: 40 mg per dose, twice daily; 1.25 m² ≤ BSA <1.5 m²: 50 mg per dose, twice daily; BSA ≥1.5 m²: 60 mg per dose, twice daily. Medication is administered consecutively for 14 days followed by a 7-day drug-free interval to complete one treatment cycle, with a total of 8 cycles planned. | Drug | High-risk adjuvant chemotherapy group (Experimental Group) |
Primary outcome
Disease-Free Survival (DFS) difference among three study arms after curative resection for stage IB-IIA gastric/gastroesophageal junction adenocarcinoma
Time frame: From randomization until 5 years after the last enrolled subject completes follow-up (median follow-up duration ≥36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Applications for data access shall be submitted to the study principal investigator upon completion of the study. The applicant is required to provide a data analysis plan, and data sharing will be approved following institutional review and assessment.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegafur Gimeracil Oteracil Potassium Capsules for oral administration in people with Stage IB-IIA Adenocarcinoma of the Stomach or Gastroesophageal Junction, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Zheng (+86 198 2975 8242, zhengrong4956@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) difference among three study arms after curative resection for stage IB-IIA gastric/gastroesophageal junction adenocarcinoma (time frame: From randomization until 5 years after the last enrolled subject completes follow-up (median follow-up duration ≥36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.