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Official title Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer
ClinicalTrials.gov ID: NCT06510010
What this study is testing
What is Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate)?
Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chemotherapy effect.
Also referred to as SOX Combined H. Pylori eradication.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study focuses on patients with H. pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- Sex is not limited and age is 18-75 years old;
You likely can't join if
- 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...
- Presence of New York Heart Association (NYHA) class III-IV cardiac insufficiency or cardiac ultrasound: LVEF (left ventricular ejection fraction) \<...
- Presence of active pulmonary tuberculosis by history or CT, or patients with a history of active pulmonary tuberculosis within 1 year prior to...
See the full eligibility criteria
- 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...
- Sex is not limited and age is 18-75 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- 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 \ 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 people not receiving anticoagulation; people receiving anticoagulation should be on a...
- 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...
- 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...
- 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 how well it works dose) or other immunosuppressive drugs within 14 days prior to first dose or during the study period. However...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.