New chemo cocktail aims to make inoperable stomach cancer removable
NCT ID NCT05184803
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three chemotherapy drugs (docetaxel, oxaliplatin, and S-1) given before surgery to people with advanced stomach cancer that cannot be removed right away. The goal is to shrink the tumor enough so that surgery can remove it completely. About 63 adults with stomach cancer that has spread to nearby tissues or lymph nodes will participate.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 63 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically or cytologically proven metastatic gastric adenocarcinoma patients 2. As a patient who has been proven by CT to have invasion of surrounding organs (T4) according to the 8th edition of the American Joint Commission (AJCC) or confined to remote lymph nodes, the criteria for lymph node invasion are 8 mm or more in single diameter and central necrosis (rounder), (Refer to Appendix B) 3. Over 18 years old. 4. Patients with a life expectancy of at least 3 months. 5. Patients with 0 or 1 ECOG performance status 6. As defined in the relevant items below, those who have confirmed appropriate normal organ and bone marrow function: * Haemoglobin 9 9.0 g/dL. * Absolute neutrophil count (ANC) \> 1.5 x 103/mCL (\> 1,500 per mm3) * Platelet count 100 100 x 109/L * Serum bilirubin 1.5 1.5 x Test Laboratory Upper Limit of Normal (ULN). * AST(SGOT)/ALT(SGPT) 2.5 2.5x ULN of test institution. * Measured creatinine clearance (CL) \> 40 mL/min or Cockcroft-Gault formula (Cockcroft and Gault 1976) calculated by or according to 24-hour urine samples for determining creatinine cleaning rates. * Male creatinine CL (mL/min) = Weight (kg)x (140-age) / 72x Serum creatinine (mg/dL) * Women's creatinine CL (mL/min) = Weight (kg)x (140-age) / 72 x Serum creatinine (mg/dL) x 0.85 7. A patient who has never had chemotherapy before. 8. Patients who have not previously had radiation therapy experience 9. Physical, family, social, and geographic conditions for the follow-up of patient conditions required for this study should be free of obstacles in this study. 10. Evidence of menopause or negative findings of urine or blood pregnancy response should be confirmed in premenopausal women. Women who are premenstrual for more than 12 months without any other medical cause are considered menopause. In addition, if bilateral ovarian resection, bilateral ovariectomy, and hysterectomy are performed, menopause is considered. 11. Subjects who can provide signed consent, such as compliance with the requirements and taboos specified in the test subject's consent (ICF) and this plan. Written consent must be obtained from the patient and the patient's legal representative prior to implementing the plan-related procedures, including screening evaluation. Exclusion Criteria: 1. When pregnant women, lactating women, or pregnant women do not use appropriate contraception methods. 2. Cancer other than adenocarcinoma. 3. Patients with distant metastasis other than lymph nodes or confirmed ascites on abdominal CT before surgery. 4. History of other carcinomas or presence of pathogenic cancer (excluding non-melanoma skin cancer or cervical epithelial cancer) 5. Central nervous system metastasis. 6. Clinically significant intestinal obstruction or gastrointestinal bleeding. 7. A patient with a history of organ transplantation. 8. Active infections such as tuberculosis, hepatitis B, hepatitis C, or HIV identified by TB tests according to medical history, physical examination, radiological findings, and regional standards. * Tuberculosis: Tuberculosis confirmed by medical history, physical examination, or radiologically active tuberculosis, and tuberculosis tests according to regional standards (excluding active TB, old TB is acceptable) * Hepatitis B: If HBsAg is negative, register, and if HBsAg is positive, HBV DNA test is performed. * HBV DNA 500 500iu/ml (or 2500 copies/ml): Excluded * HBV DNA ▶500iu/ml (or 2500 copies/ml): Allow * Hepatitis C: If HCV Ab is negative, register, and if HCV Ab is positive, HCV RNA test is performed. * If HCV RNA is positive, I'll exclude it. * If it's HCV RNA's voice, it's allowed. * HIV: HIV Ag/Ab : excluding reactive faces, HIV Ag/Ab : non-reactive faces registration 9. Average QTcF (average QT interval for heart rate correction using fridericia formula) \> 470 ms when calculated with three ECG tests (within 15 minutes at 2-5 minute intervals). If -1 test is performed and QTcF \> 470 ms, 2 additional tests are performed to determine the average QTcF value. -If QTcF 4 470 ms after one test, no additional test is performed. 10. Other serious diseases or medical conditions. * Uncurable unstable heart disease, myocardial infarction within 6 months before the start of the study. * A history of neurological or psychiatric diseases including dementia or seizures. * Active, non-regulatory infection. * Clinically serious diarrhea. * Severe high calcium conditions above 12 mg/dL, which are not controlled by phonates. * Other serious medical conditions that may affect participation in this study. * Active random intravascular coagulation. 11. Patients who other researchers find inappropriate. 12. In the case of recent corticosteroids (or corresponding) treatment, except for acute hypersensitivity response therapy or low-dose (\<20 mg methylprednisolone or corresponding) chronic treatment (started 6 months before the start of the study) as preventive therapy, 13. In addition to the test drug, administration of other clinical research drugs within 4 weeks or in combination. 14. Combination chemotherapy, hormone therapy, or immunotherapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center, University of Ulsan College of Medicine
RECRUITINGSeoul, Seoul, 138-736, South Korea
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