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New chemo cocktail aims to make inoperable stomach cancer removable

NCT ID NCT05184803

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 63 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

19 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Asan Medical Center, University of Ulsan College of Medicine

    RECRUITING

    Seoul, Seoul, 138-736, South Korea

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