Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 19 and up

Neoadjuvant chemotherapy for advanced gastric cancer with lymph node metastasis

Official title: A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer

Run by Asan Medical Center · NCT05184803 · Data updated 2026-11-12

This study is testing a new combination of chemotherapy drugs to see if it can help people with advanced stomach cancer that has spread to lymph nodes get better and have successful surgery.

Quick facts

PhasePhase 2
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment63 (estimated)
SponsorAsan Medical Center
Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations1 site (Seoul, Seoul)
StatusRecruiting
StartedMarch 23, 2022
Main results expectedJune 30, 2027
Study endsDecember 31, 2027
Registry record updatedApril 7, 2026
Trial IDNCT05184803 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 with histologically confirmed metastatic gastric adenocarcinoma and specific criteria for tumor invasion and lymph node involvement.

Probably not a fit

Patients with gastric cancer that is not metastatic or those with significant comorbidities affecting treatment tolerance may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a combination of Docetaxel, Oxaliplatin, and S-1 as neoadjuvant chemotherapy in patients with unresectable locally advanced gastric cancer or distant metastasis limited to lymph nodes. The study aims to improve the R0 resection rate and overall survival by intensifying chemotherapy before surgical intervention. Participants will receive these treatments to assess their response and potential for subsequent surgical resection. The trial is particularly focused on patients with specific criteria related to tumor invasion and lymph node involvement.

Why it matters

Potential benefit: If successful, this approach could enhance surgical outcomes and survival rates for patients with advanced gastric cancer.

How similar studies have gone: Previous studies have shown promise with similar neoadjuvant chemotherapy approaches in gastric cancer, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Asan Medical Center, University of Ulsan College of Medicine
    Seoul, Seoul, South Korea
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.