Chemotherapy EffectPhase 2NCT06510010
Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer
A Phase 2 study testing Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate) and Oxaliplatin With S-1 （SOX） in people with Chemotherapy Effect, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This study focuses on patients with H. pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction. It evaluates the perioperative oxaliplatin with S-1 (SOX) combined H. pylori eradication versus oxaliplatin with S-1 in the management of H. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate) and Oxaliplatin With S-1 （SOX）
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Jul 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have been fully informed about the study and voluntarily signed the informed consent form (ICF);
- Gastroscopy pathology confirmed locally advanced adenocarcinoma of the gastric and oesophagogastric junction (Siewert type I-III);
- Clinical (enhanced CT, enhanced MRI, or PET-CT) staging at the time of diagnosis: cT3/4a Nx or T2 N2/3, M0 (The American Joint Committee on Cancer 8th edition):
- The present H. Pylori infection at the time of diagnosis is determined by one of the following 3 items: ① Positive gastric mucosal tissue rapid urease test (RUT), tissue section staining, or bacterial culture for any of the 3 items. Positive 13C or 14C-urea breath test (UBT). ③ Positive helicobacter pylori stool antigen (HpSA) tests (clinically validated monoclonal antibody method). Positive serum H. Pylori antibody test (clinically proven reagent with high accuracy) suggests previous infection, and those who have never been treated can be considered as having current infection;
- Sex is not limited and age is 18-75 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
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- Organ function permits major abdominal surgery;
- Expected survival ≥ 6 months;
- Laboratory test values must meet the following criteria within 7 days prior to enrollment:
- whole-body cryotherapy/cryostimulation (WBC) > 4.0 × 10^9/L and < 15 × 10^9/L, ANC > 1.5 × 10^9/L, Hb ≥ 75 g/L, PLT ≥ 100 × 10^9/L;
- Serum bilirubin ≤ 1.5 x high limit of normal, aspartate transaminase (AST), alanine aminotransferase (ALT) ≤ 2.5 x high limit of normal;
- Creatinine ≤ 1.5 x high limit of normal or creatinine clearance rate > 60 ml/min;
- international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × Upper limit of normal ( ULN ) only for subjects not receiving anticoagulation; subjects receiving anticoagulation should be on a stable dose;
- Ability to cooperate with the appropriate endoscopic, laboratory and imaging tests for this protocol;
- Females of childbearing potential (including females who are menopausal due to chemo-menopause or other medical reasons) must agree to use contraception for a period of at least 6 months from the time of signing the Informed Consent Form to at least 6 months after the last dose of study treatment or concomitant chemotherapy, whichever is later. Females must also agree to refrain from breastfeeding for a period of at least 6 months from the time of signing the informed consent to the time of the last administration of the study drug or concomitant chemotherapy, whichever is later; males must agree to use contraception for a period of at least 6 months from the time of administration of the test drug to the time of the last administration of the test drug or concomitant chemotherapy, whichever is later.
Who cannot join
- Stage IV or unresectable gastric or gastroesophageal junction cancer as determined by the investigator;
- Other active malignancies within 5 years or concurrently.
- Patients who are preparing for or have previously received organ or bone marrow transplantation;
- Myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women) within 6 months prior to the first dose (QTc interval is calculated by the Fridericia formula);
- Presence of New York Heart Association (NYHA) class III-IV cardiac insufficiency or cardiac ultrasound: LVEF (left ventricular ejection fraction) < 50%;
- Presence of active pulmonary tuberculosis by history or CT, or patients with a history of active pulmonary tuberculosis within 1 year prior to enrollment, or patients with a history of active pulmonary tuberculosis more than 1 year prior but without regular treatment;
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- Presence of a known active or suspected autoimmune disease. The exception is those who are in a stable state of that disease at the time of enrollment (not requiring systemic immunosuppression therapy);
- Received a live vaccine within 28 days prior to the first dose; except inactivated viral vaccines for seasonal influenza;
- Patients requiring treatment with systemic corticosteroids (> 10 mg/day prednisone efficacy dose) or other immunosuppressive drugs within 14 days prior to first dose or during the study period. However, enrollment is permitted if patients are allowed to be treated with topical topical or inhaled steroids, or adrenal hormone replacement therapy at doses ≤ 10 mg/day prednisone efficacy dose in the absence of active autoimmune disease;
- Undergoing treatment in another clinical study or scheduled to begin treatment in this study less than 14 days from the end of treatment in the previous clinical study;
- Known history of severe allergy to any study drug excipients;
- known history of psychotropic pharmaceuticals abuse or drug addiction; patients who have stopped drinking alcohol can be enrolled;
- Presence of patients with conditions that may increase the risk of study medication, or other severe, acute and chronic medical conditions that, in the judgment of the investigator, make participation in a clinical study unsuitable.
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 Sixth Affiliated Hospital，Sun Yat-sen University
Guangzhou
Lei Lian, Department Director, 17776474913, lianlei2@mail.sysu.edu.cn
About this study
Official title: Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Adenocarcinoma of the Gastric and Oesophagogastric Junction: an Open-label, Prospective, Multicenter, Randomised, Phase 2 Trial.
This study focuses on patients with H. pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction. It evaluates the perioperative oxaliplatin with S-1 (SOX) combined H. pylori eradication versus oxaliplatin with S-1 in the management of H. pylori-positive locally advanced adenocarcinoma of the gastric and oesophagogastric junction (cT3/4a Nx or T2 N2/3, M0) , assessing their values and advantages.
Read the detailed description
Subjects randomized to the trial group will receive 3-4 cycles of oxaliplatin with S-1 (SOX)+ H. pylori eradication (a 14-day quadruple regimen: amoxicillin + clarithromycin + omeprazole + bismuth potassium citrate) before surgery. One of the SOX regimens will be every 3 weeks (Q3W), with a tumor response assessment at the end of the neoadjuvant therapy course. Patients will continue to receive 4-5 cycles of SOX adjuvant chemotherapy after surgery for a total of 8 cycles of SOX regimen treatment. Patients in the trial group will undergo H. pylori eradication at the time of the first cycle of the SOX regimen. H. pylori eradication will be determined by postoperative pathology, and those who are H. pylori-positive by postoperative pathology will be treated with remedial eradication therapy after recovery from surgery (except for patients with total gastric resection).
Subjects randomized to the control group will receive 3-4 cycles of neoadjuvant therapy with the SOX regimen before surgery. The SOX regimen will be administered every 3 weeks (Q3W). A tumor response assessment will be performed at the end of the treatment course. Control patients were treated with H. pylori eradication after recovery from surgery based on postoperative pathologic H. pylori results: if H. pylori-positive, they received H. pylori eradication plus 4-5 cycles of SOX adjuvant chemotherapy (except for patients who underwent total gastric resection); if H. pylori-negative, they received 4-5 cycles of SOX adjuvant chemotherapy only.
A formal interim analysis will schedule once 60 enrolled participants have completed the primary endpoint. This analysis will serve as the decisive basis for determining whether to terminate this study early. Criteria for early termination are as follows: (i) Efficacy-driven termination: If the analysis of the primary outcome across the 60 participants achieves statistical significance (p < 0.05), indicating that the anticipated clinical trial objectives have been fully realized, patient enrollment will be discontinued immediately. (ii) Feasibility-driven termination: If the analysis fails to reach statistical significance, a scientific and feasibility assessment will be initiated to determine whether to prematurely halt or proceed with subsequent enrollment.
- Conditions
- Chemotherapy Effect
- Being tested
- Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate), Oxaliplatin With S-1 （SOX）
- Keywords
- H. Pylori Eradication, Perioperative chemotherapy, Locally Advanced Gastric Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate)Drug
Also called SOX Combined H. Pylori eradication
Oxaliplatin With S-1 (SOX) regimen:
S-1: 40mg/m2, oral, bid, D1-14, one cycle every 3 weeks; Oxaliplatin: 130 mg/m2, IV, qd, D1, every 3 weeks for one cycle.
- pylori eradication regimen:
- pylori eradication was performed using a quadruple regimen for 14 d. Omeprazole 20 mg bid+Colloidal bismuth subcitrate 220mg bid+Amoxicillin 1g bid+Clarithromycin 500mg bid.
Oxaliplatin With S-1 （SOX）Drug
Also called SOX
Oxaliplatin With S-1 （SOX） regimen:
S-1: 40mg/m2, oral, bid, D1-14, one cycle every 3 weeks; Oxaliplatin: 130 mg/m2, IV, qd, D1, every 3 weeks for one cycle.
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin With S-1 （SOX）Combined H. Pylori Eradication | Experimental | Subjects randomized to the trial group will receive 3-4 cycles of Oxaliplatin With S-1 （SOX）+ H. pylori eradication (a 14-day quadruple regimen: amoxicillin + clarithromycin + omeprazole + bismuth potassium citrate) before surgery. One of the SOX regimens will be every 3 weeks (Q3W), with a tumor response assessment at the end of the neoadjuvant therapy course. Patients will continue to receive 4-5 cycles of SOX adjuvant chemotherapy after surgery for a total of 8 cycles of SOX regimen treatment. Patients in the trial group will undergo H. pylori eradication at the time of the first cycle of the SOX regimen. H. pylori eradication will be determined by postoperative pathology, and those who are H. pylori-positive by postoperative pathology will be treated with remedial eradication therapy after recovery from surgery (except for patients with total gastric resection). Receives: Drug: Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate) |
| Oxaliplatin With S-1 （SOX） | Active comparator | Subjects randomized to the control group will receive 3-4 cycles of neoadjuvant therapy with the Oxaliplatin With S-1（SOX）regimen before surgery. The SOX regimen will be administered every 3 weeks (Q3W). A tumor response assessment will be performed at the end of the treatment course. Control patients were treated with H. Pylori eradication after recovery from surgery based on postoperative pathologic H. Pylori results: if H. Pylori-positive, they received H. Pylori eradication plus 4-5 cycles of SOX adjuvant chemotherapy (except for patients who underwent total gastric resection); if H. Pylori-negative, they received 4-5 cycles of SOX adjuvant chemotherapy only. Receives: Drug: Oxaliplatin With S-1 （SOX） |
What is being measured
The primary outcome is the main question the study is designed to answer.
major pathological response (MPR)
MPR defined as a tumor regression grade (TRG) score of 0-1; TRG 0 represents complete remission (no residual cancer cells), TRG 1 meant significant remission (residual lesions < 10%)
Measured: Through postoperative pathology, an average of 2 week
Secondary outcomes (6)
pathological complete response (pCR)
pCR defined as tumor regression grade (TRG) score of 0；TRG 0 represents complete remission (no residual cancer cells)
Measured: Through postoperative pathology, an average of 2 week
overall survival （OS）
Overall survival （OS） refers to the time from the beginning of randomization to death from any cause.
Measured: From date of first administration until the date of death from any cause, assessed up to 36 months"
disease-free survival (DFS)
Disease-free survival (DFS) refers to the time from the beginning of randomization to the recurrence of the disease or death from any cause (whichever occurs first).
Measured: From the date of first administration until the date of first disease recurrence or date of death from any cause, whichever came first, assessed up to 36 months.
adverse events (AE)
Adverse events (AE) means all adverse medical events that occur after the subject has received the experimental medication.
Measured: From the beginning of the first neoadjuvant chemotherapy to 60 days after the last adjuvant chemotherapy
serious adverse events (SAE)
Serious adverse events (SAE) means an adverse medical event resulting in death, life-threatening, permanent or severe disability or loss of function, the need for or prolongation of hospitalization of the subject, and congenital anomalies or birth defects after the subject has received the experimental medication.
Measured: From the beginning of the first neoadjuvant chemotherapy to 60 days after the last adjuvant chemotherapy
R0 resection rate
No cancer cells could be found at the cut edge of the specimen under the microscope, and no cancer cells remained either visually or microscopically; the lesion was completely removed.
Measured: Through postoperative pathology, an average of 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start31 Dec 2024
- Primary completion28 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- 198 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Lian, Ph.D, Principal investigator, Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510010
- Sponsor's protocol ID
- 2024ZSLYEC-340
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Adenocarcinoma of the Gastric and Oesophagogastric Junction: an Open-label, Prospective, Multicenter, Randomised, Phase 2 Trial.
- ClinicalTrials.gov ID
- NCT06510010
- Acronym / sponsor ID
- 2024ZSLYEC-340
- Conditions
- Chemotherapy Effect
- Keywords
- H. Pylori Eradication, Perioperative chemotherapy, Locally Advanced Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Jul 2024 (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 focuses on patients with H. pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction. It evaluates the perioperative oxaliplatin with S-1 (SOX) combined H. pylori eradication versus oxaliplatin with S-1 in the management of H. pylori-positive locally advanced adenocarcinoma of the gastric and oesophagogastric junction (cT3/4a Nx or T2 N2/3, M0) , assessing their values and advantages.
Detailed description
Subjects randomized to the trial group will receive 3-4 cycles of oxaliplatin with S-1 (SOX)+ H. pylori eradication (a 14-day quadruple regimen: amoxicillin + clarithromycin + omeprazole + bismuth potassium citrate) before surgery. One of the SOX regimens will be every 3 weeks (Q3W), with a tumor response assessment at the end of the neoadjuvant therapy course. Patients will continue to receive 4-5 cycles of SOX adjuvant chemotherapy after surgery for a total of 8 cycles of SOX regimen treatment. Patients in the trial group will undergo H. pylori eradication at the time of the first cycle of the SOX regimen. H. pylori eradication will be determined by postoperative pathology, and those who are H. pylori-positive by postoperative pathology will be treated with remedial eradication therapy after recovery from surgery (except for patients with total gastric resection).
Subjects randomized to the control group will receive 3-4 cycles of neoadjuvant therapy with the SOX regimen before surgery. The SOX regimen will be administered every 3 weeks (Q3W). A tumor response assessment will be performed at the end of the treatment course. Control patients were treated with H. pylori eradication after recovery from surgery based on postoperative pathologic H. pylori results: if H. pylori-positive, they received H. pylori eradication plus 4-5 cycles of SOX adjuvant chemotherapy (except for patients who underwent total gastric resection); if H. pylori-negative, they received 4-5 cycles of SOX adjuvant chemotherapy only.
A formal interim analysis will schedule once 60 enrolled participants have completed the primary endpoint. This analysis will serve as the decisive basis for determining whether to terminate this study early. Criteria for early termination are as follows: (i) Efficacy-driven termination: If the analysis of the primary outcome across the 60 participants achieves statistical significance (p < 0.05), indicating that the anticipated clinical trial objectives have been fully realized, patient enrollment will be discontinued immediately. (ii) Feasibility-driven termination: If the analysis fails to reach statistical significance, a scientific and feasibility assessment will be initiated to determine whether to prematurely halt or proceed with subsequent enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin With S-1 （SOX）Combined H. Pylori Eradication | Experimental | Drug: Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate)Subjects randomized to the trial group will receive 3-4 cycles of Oxaliplatin With S-1 （SOX）+ H. pylori eradication (a 14-day quadruple regimen: amoxicillin + clarithromycin + omeprazole + bismuth potassium citrate) before surgery. One of the SOX regimens will be every 3 weeks (Q3W), with a tumor response assessment at the end of the neoadjuvant therapy course. Patients will continue to receive 4-5 cycles of SOX adjuvant chemotherapy after surgery for a total of 8 cycles of SOX regimen treatment. Patients in the trial group will undergo H. pylori eradication at the time of the first cycle of the SOX regimen. H. pylori eradication will be determined by postoperative pathology, and those who are H. pylori-positive by postoperative pathology will be treated with remedial eradication therapy after recovery from surgery (except for patients with total gastric resection). |
| Oxaliplatin With S-1 （SOX） | Active comparator | Drug: Oxaliplatin With S-1 （SOX）Subjects randomized to the control group will receive 3-4 cycles of neoadjuvant therapy with the Oxaliplatin With S-1（SOX）regimen before surgery. The SOX regimen will be administered every 3 weeks (Q3W). A tumor response assessment will be performed at the end of the treatment course. Control patients were treated with H. Pylori eradication after recovery from surgery based on postoperative pathologic H. Pylori results: if H. Pylori-positive, they received H. Pylori eradication plus 4-5 cycles of SOX adjuvant chemotherapy (except for patients who underwent total gastric resection); if H. Pylori-negative, they received 4-5 cycles of SOX adjuvant chemotherapy only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- have been fully informed about the study and voluntarily signed the informed consent form (ICF);
- Gastroscopy pathology confirmed locally advanced adenocarcinoma of the gastric and oesophagogastric junction (Siewert type I-III);
- Clinical (enhanced CT, enhanced MRI, or PET-CT) staging at the time of diagnosis: cT3/4a Nx or T2 N2/3, M0 (The American Joint Committee on Cancer 8th edition):
- The present H. Pylori infection at the time of diagnosis is determined by one of the following 3 items: ① Positive gastric mucosal tissue rapid urease test (RUT), tissue section staining, or bacterial culture for any of the 3 items. Positive 13C or 14C-urea breath test (UBT). ③ Positive helicobacter pylori stool antigen (HpSA) tests (clinically validated monoclonal antibody method). Positive serum H. Pylori antibody test (clinically proven reagent with high accuracy) suggests previous infection, and those who have never been treated can be considered as having current infection;
- Sex is not limited and age is 18-75 years old;
Key exclusion criteria (13 listed)
- Stage IV or unresectable gastric or gastroesophageal junction cancer as determined by the investigator;
- Other active malignancies within 5 years or concurrently.
- Patients who are preparing for or have previously received organ or bone marrow transplantation;
- Myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women) within 6 months prior to the first dose (QTc interval is calculated by the Fridericia formula);
- Presence of New York Heart Association (NYHA) class III-IV cardiac insufficiency or cardiac ultrasound: LVEF (left ventricular ejection fraction) < 50%;
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 |
|---|---|---|
| Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate)Also: SOX Combined H. Pylori eradicationOxaliplatin With S-1 (SOX) regimen: S-1: 40mg/m2, oral, bid, D1-14, one cycle every 3 weeks; Oxaliplatin: 130 mg/m2, IV, qd, D1, every 3 weeks for one cycle. H. pylori eradication regimen: H. pylori eradication was performed using a quadruple regimen for 14 d. Omeprazole 20 mg bid+Colloidal bismuth subcitrate 220mg bid+Amoxicillin 1g bid+Clarithromycin 500mg bid. | Drug | Oxaliplatin With S-1 （SOX）Combined H. Pylori Eradication |
| Oxaliplatin With S-1 （SOX）Also: SOXOxaliplatin With S-1 （SOX） regimen: S-1: 40mg/m2, oral, bid, D1-14, one cycle every 3 weeks; Oxaliplatin: 130 mg/m2, IV, qd, D1, every 3 weeks for one cycle. | Drug | Oxaliplatin With S-1 （SOX） |
Primary outcome
major pathological response (MPR)
Time frame: Through postoperative pathology, an average of 2 week
MPR defined as a tumor regression grade (TRG) score of 0-1; TRG 0 represents complete remission (no residual cancer cells), TRG 1 meant significant remission (residual lesions < 10%)
6 secondary outcomes
pathological complete response (pCR)
Time frame: Through postoperative pathology, an average of 2 week
overall survival （OS）
Time frame: From date of first administration until the date of death from any cause, assessed up to 36 months"
disease-free survival (DFS)
Time frame: From the date of first administration until the date of first disease recurrence or date of death from any cause, whichever came first, assessed up to 36 months.
adverse events (AE)
Time frame: From the beginning of the first neoadjuvant chemotherapy to 60 days after the last adjuvant chemotherapy
serious adverse events (SAE)
Time frame: From the beginning of the first neoadjuvant chemotherapy to 60 days after the last adjuvant chemotherapy
R0 resection rate
Time frame: Through postoperative pathology, an average of 2 week
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 6 Aug 2026.
- Individual participant dataSharing planned: No. There are no plan to make individual participant data (IPD) available to other researchers.
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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.
Lei Lian, Ph.D principal investigator
Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University
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 Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate) and Oxaliplatin With S-1 （SOX） in people with Chemotherapy Effect, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 15 inclusion and 13 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 6 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 Bin Zhong (17776474913, zhongb9@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major pathological response (MPR) (time frame: Through postoperative pathology, an average of 2 week). 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 6 Aug 2026.