IB-II Gastric CancerPhase 2NCT07788196
A Clinical Study Comparing Anti-HER2 Therapy Combined With Chemotherapy to Chemotherapy Alone as Adjuvant Therapy Following Surgery for Stage IB-II Gastric Cancer With High HER2 Expression.
A Phase 2 study testing Trastuzumab, Monotherapy with tegafur for stage IB gastric cancer and Stage II gastric cancer treated with the SOX or XELOX regimens in people with IB-II Gastric Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
This study employs a multicenter randomized controlled trial design, led by the First Affiliated Hospital of Air Force Medical University (Xijing Hospital) in collaboration with 10 other domestic medical institutions, for a total of 11 research centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IB-II Gastric Cancer
- What is being tested?
- Trastuzumab, Monotherapy with tegafur for stage IB gastric cancer and Stage II gastric cancer treated with the SOX or XELOX regimens
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to Dec 2030
- Phase
- Phase 2
- 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
- Age ≥ 18 years; Open to all genders;
- Patients with a definitive histopathological diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and an ECOG score ≤ 2;
- Gastric cancer or gastroesophageal junction cancer with TNM stage IB-II;
- HER-2-positive (IHC 3+ or IHC 2+ with amplification confirmed by FISH/SISH/CISH);
- Tumor resection has been completed, and adjuvant therapy is planned postoperatively;
- Adequate organ function; participants must meet the following laboratory criteria:
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- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, without the use of granulocyte colony-stimulating factor (G-CSF) within the past 14 days;
- Platelet count ≥ 100 × 10⁹/L, without a blood transfusion within the past 14 days;
- Hemoglobin > 9 g/dL, without a blood transfusion or the use of erythropoietin within the past 14 days;
- 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 creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL/min;
- Normal coagulation function, defined as an International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5 times the ULN;
- Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may still be enrolled provided that total T3 (or FT3) and FT4 are within the normal range;
- Cardiac enzyme levels are within the normal range (participants with isolated laboratory abnormalities deemed clinically insignificant by the investigator's comprehensive assessment may also be enrolled);
- Voluntary participation in the study and signing of an informed consent form prior to study initiation.
Who cannot join
- Other malignant tumors of the stomach;
- Received, prior to screening, or is scheduled to receive during the trial any anticancer therapy other than the chemotherapy regimen specified in the protocol (e.g., radiation therapy, targeted therapy, immunotherapy);
- Has or has had a malignant tumor in any other part of the body (except for adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, or other tumors that have been surgically cured and have not recurred for at least 5 years);
- Presence of any severe or uncontrolled systemic disease, such as:
- Unstable angina, congestive heart failure, or chronic heart failure classified as New York Heart Association (NYHA) Class ≥ 2;
- Significant and symptomatic, difficult-to-control abnormalities in rhythm, conduction, or morphology on a resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation;
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- Any arterial thrombosis, embolism, or ischemia occurring within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack;
- Poorly controlled blood pressure (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg);
- A history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease;
- Active pulmonary tuberculosis;
- Active or uncontrolled infection requiring systemic treatment;
- Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction;
- Liver disease, such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis;
- Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L);
- Patients with urine protein ≥++ on urinalysis and confirmed 24-hour urine protein quantification > 1.0 g;
- Patients with psychiatric disorders who are unable to comply with treatment;
- Patients currently participating in other clinical trials or who have participated in other clinical trials within the past 3 months;
- Patients with known allergies to the medications used in this study;
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
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
Official title: A Randomized, Controlled, Open-Label, Multicenter Clinical Trial Comparing Anti-HER2 Therapy Combined With Chemotherapy to Chemotherapy Alone as Adjuvant Therapy Following Surgery for Stage IB-II Gastric Cancer With High HER2 Expression
This study employs a multicenter randomized controlled trial design, led by the First Affiliated Hospital of Air Force Medical University (Xijing Hospital) in collaboration with 10 other domestic medical institutions, for a total of 11 research centers. The study plans to enroll a total of 120 HER-2-positive gastric cancer patients, including those who drop out, and randomize them into two groups in a 1:1 ratio; The control group received treatment based on gastric cancer stage: Stage IB patients were treated with tegafur monotherapy (40-60 mg orally twice daily based on body surface area, on days 1-14, with a 21-day cycle, for a total of 6 cycles); Stage II patients will receive chemotherapy using either the SOX or XELOX regimen, both of which involve an intravenous infusion of oxaliplatin 130 mg/m² on Day 1, combined with the corresponding oral medications for 14 consecutive days, with a 21-day cycle, for a total of 6 treatment cycles; In addition to the control group's original chemotherapy regimen, the experimental group concurrently received Fuhong Hanlin trastuzumab (National Drug Approval No. S20200019, 150 mg/vial) in addition to the control group's original chemotherapy regimen. The first dose was an 8 mg/kg intravenous loading dose, followed by a maintenance dose of 6 mg/kg, administered concurrently starting on the first day of the first chemotherapy cycle, with each cycle lasting 21 days, and the treatment course consisting of 6 cycles.
- Conditions
- IB-II Gastric Cancer
- Being tested
- Trastuzumab, Monotherapy with tegafur for stage IB gastric cancer, Stage II gastric cancer treated with the SOX or XELOX regimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabBiological
Administer an initial loading dose of 8 mg/kg, followed by 6 mg/kg intravenously. Administer concurrently with chemotherapy, beginning on Day 1 of the first chemotherapy cycle. One cycle consists of 21 days. A total of 6 cycles are administered.
Monotherapy with tegafur for stage IB gastric cancerDrug
Monotherapy with tegafur for stage IB gastric cancer:
Tegafur 40-60 mg (based on body surface area), taken orally twice daily on days 1-14. One cycle consists of 21 days, for a total of 6 cycles.
Stage II gastric cancer treated with the SOX or XELOX regimensDrug
SOX or XELOX regimens for Stage II gastric cancer:
SOX regimen: Oxaliplatin 130 mg/m², administered by intravenous infusion on Day 1; tegafur 40-60 mg (based on body surface area), taken orally twice daily on Days 1-14. One cycle consists of 21 days, for a total of 6 cycles.
XELOX regimen: Oxaliplatin 130 mg/m², administered by intravenous infusion on Day 1; capecitabine 1000 mg/m², administered orally twice daily on Days 1-14. One cycle consists of 21 days, for a total of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Drug: Monotherapy with tegafur for stage IB gastric cancer; Drug: Stage II gastric cancer treated with the SOX or XELOX regimens |
| Experimental Group | Experimental | Not described Receives: Biological: Trastuzumab; Drug: Monotherapy with tegafur for stage IB gastric cancer; Drug: Stage II gastric cancer treated with the SOX or XELOX regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Disease-Free Survival (DFS).
Measured: 5 years after study randomization
Secondary outcomes (1)
Overall Survival (OS)
Measured: Up to 5 years after patient randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Jul 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IB-II Gastric CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT07788196
- Sponsor's protocol ID
- KY20262190
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study completion, researchers may apply for shared data to the study principal investigator by submitting a data analysis plan; access will be granted following official review and assessment.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label, Multicenter Clinical Trial Comparing Anti-HER2 Therapy Combined With Chemotherapy to Chemotherapy Alone as Adjuvant Therapy Following Surgery for Stage IB-II Gastric Cancer With High HER2 Expression
- ClinicalTrials.gov ID
- NCT07788196
- Acronym / sponsor ID
- KY20262190
- Conditions
- IB-II Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 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 employs a multicenter randomized controlled trial design, led by the First Affiliated Hospital of Air Force Medical University (Xijing Hospital) in collaboration with 10 other domestic medical institutions, for a total of 11 research centers. The study plans to enroll a total of 120 HER-2-positive gastric cancer patients, including those who drop out, and randomize them into two groups in a 1:1 ratio; The control group received treatment based on gastric cancer stage: Stage IB patients were treated with tegafur monotherapy (40-60 mg orally twice daily based on body surface area, on days 1-14, with a 21-day cycle, for a total of 6 cycles); Stage II patients will receive chemotherapy using either the SOX or XELOX regimen, both of which involve an intravenous infusion of oxaliplatin 130 mg/m² on Day 1, combined with the corresponding oral medications for 14 consecutive days, with a 21-day cycle, for a total of 6 treatment cycles; In addition to the control group's original chemotherapy regimen, the experimental group concurrently received Fuhong Hanlin trastuzumab (National Drug Approval No. S20200019, 150 mg/vial) in addition to the control group's original chemotherapy regimen. The first dose was an 8 mg/kg intravenous loading dose, followed by a maintenance dose of 6 mg/kg, administered concurrently starting on the first day of the first chemotherapy cycle, with each cycle lasting 21 days, and the treatment course consisting of 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Monotherapy with tegafur for stage IB gastric cancer, Drug: Stage II gastric cancer treated with the SOX or XELOX regimens |
| Experimental Group | Experimental | Biological: Trastuzumab, Drug: Monotherapy with tegafur for stage IB gastric cancer, Drug: Stage II gastric cancer treated with the SOX or XELOX regimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years; Open to all genders;
- Patients with a definitive histopathological diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and an ECOG score ≤ 2;
- Gastric cancer or gastroesophageal junction cancer with TNM stage IB-II;
- HER-2-positive (IHC 3+ or IHC 2+ with amplification confirmed by FISH/SISH/CISH);
- Tumor resection has been completed, and adjuvant therapy is planned postoperatively;
Key exclusion criteria (19 listed)
- Other malignant tumors of the stomach;
- Received, prior to screening, or is scheduled to receive during the trial any anticancer therapy other than the chemotherapy regimen specified in the protocol (e.g., radiation therapy, targeted therapy, immunotherapy);
- Has or has had a malignant tumor in any other part of the body (except for adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, or other tumors that have been surgically cured and have not recurred for at least 5 years);
- Presence of any severe or uncontrolled systemic disease, such as:
- Unstable angina, congestive heart failure, or chronic heart failure classified as New York Heart Association (NYHA) Class ≥ 2;
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 |
|---|---|---|
| TrastuzumabAdminister an initial loading dose of 8 mg/kg, followed by 6 mg/kg intravenously. Administer concurrently with chemotherapy, beginning on Day 1 of the first chemotherapy cycle. One cycle consists of 21 days. A total of 6 cycles are administered. | Biological | Experimental Group |
| Monotherapy with tegafur for stage IB gastric cancerMonotherapy with tegafur for stage IB gastric cancer: Tegafur 40-60 mg (based on body surface area), taken orally twice daily on days 1-14. One cycle consists of 21 days, for a total of 6 cycles. | Drug | Control Group, Experimental Group |
| Stage II gastric cancer treated with the SOX or XELOX regimensSOX or XELOX regimens for Stage II gastric cancer: SOX regimen: Oxaliplatin 130 mg/m², administered by intravenous infusion on Day 1; tegafur 40-60 mg (based on body surface area), taken orally twice daily on Days 1-14. One cycle consists of 21 days, for a total of 6 cycles. XELOX regimen: Oxaliplatin 130 mg/m², administered by intravenous infusion on Day 1; capecitabine 1000 mg/m², administered orally twice daily on Days 1-14. One cycle consists of 21 days, for a total of 6 cycles. | Drug | Control Group, Experimental Group |
Primary outcome
5-year Disease-Free Survival (DFS).
Time frame: 5 years after study randomization
1 secondary outcome
Overall Survival (OS)
Time frame: Up to 5 years after patient randomization
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 26 Aug 2026.
- Individual participant dataSharing planned: Yes. After study completion, researchers may apply for shared data to the study principal investigator by submitting a data analysis plan; access will be granted following official review and assessment.
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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 Phase 2 study testing Trastuzumab, Monotherapy with tegafur for stage IB gastric cancer and Stage II gastric cancer treated with the SOX or XELOX regimens in people with IB-II Gastric Cancer, 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 16 inclusion and 19 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 26 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yongzhan Nie (+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?
5-year Disease-Free Survival (DFS). (time frame: 5 years after study randomization). 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 26 Aug 2026.