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

Launched by ASAN MEDICAL CENTER · Jan 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of chemotherapy drugs—docetaxel, oxaliplatin, and S-1—given before surgery to treat patients with advanced stomach cancer that cannot currently be removed by surgery. The goal is to see if this treatment can help shrink the cancer and increase the chances of successful surgical removal, known as R0 resection. This trial is particularly important because many patients with advanced gastric cancer face challenges in getting surgery, and researchers are hoping that this approach may improve their treatment outcomes.

To be eligible for this trial, participants need to be adults over 18 with confirmed stomach cancer that has spread to nearby lymph nodes or organs. They should not have received any chemotherapy or radiation before. If you join the trial, you can expect to receive the chemotherapy for several cycles before surgery, and the study will carefully monitor your response to treatment and any side effects you may experience. Taking part in this trial may provide access to new treatment options and contribute to important research in improving care for gastric cancer patients.

Gender

ALL

Eligibility 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.