None listed
Conditions
Interventions
Drug : Paclitaxel/Capecitabine/Oxaliplatin should be administered on Day 1 of each cycle, after completion of all procedures/evaluations. The timing of administration of chemotherapy can be adjusted w
s leave and/or public holidays), suspension of dosing is permitted. Subjects must resume study treatment within 3 weeks of the scheduled suspension to maintain the 1 cycle 3 week dosing interval. The
s study record.
-Intraperitoneal Paclitaxel 40mg/m2 is administered every 3 weeks by intraperitoneal port/catheter on Day 1 and Day 8. Before Paclitaxel is administered, drugs (eg, Peniramine, Dexame
s ascites/peritoneum condition, the amount of physiological saline infusion can be appropriately reduced. Paclitaxel'
s intraperitoneal chemotherapy is performed up to 4 cycles before surgery, and if conversion surgery is performed after 4 cycles, IP Paclitaxel is administered up to 4 cycles after surgery.
-Oxaliplat
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with gastric adenocarcinoma confirmed as advanced gastric cancer diagnosed by histological or cytopathological examination 2. Patients whose peritoneal metastasis was visually and histologically confirmed through laparoscopy or laparoscopically and corresponds to PCI <12 (including patients with cytology (+) without gross lesions) 3. Patients who have not undergone surgical resection and systemic chemotherapy for recurrent/metastatic advanced gastric cancer 4. Patients who are willing and able to prepare written subject consent for this study. 5. Patients aged 19-75 at the time of signing the subject consent form. 6. Patients with evaluable lesions according to RECIST 1.1. 7.ECOG activity status 0 or 1. 8. Patients with adequate organ function. 9. Patients of childbearing potential who have a negative pregnancy response on urine or serological tests, or who consent to the use of appropriate contraception. 4. A female patient of childbearing potential with a negative urine or serum pregnancy test performed within 72 hours prior to the first administration of the test drug. If the urine test result is positive or negative, and you are not sure, a serum pregnancy test should be performed. 5. Women of childbearing potential must agree to use two appropriate methods of contraception during the clinical trial and until the 120th day after the last dose of the test drug, or to be surgically infertile or to stop intersex sexual intercourse. A woman of childbearing potential refers to a woman who is not surgically infertile or who has not had menstruation for more than one year. 6. Male patients should agree to continue using the appropriate contraceptive method from the first administration of the test drug to the 120th day after the last administration.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received systemic chemotherapy for recurrent/metastatic advanced gastric cancer 2. Patients with distant metastasis other than the peritoneum or metastasis of aortic or retroperitoneal lymph nodes (however, if surgical resection is possible due to ovarian metastasis, registration is possible) 3 If complete resection of the primary lesion is impossible due to direct infiltration of important organs (however, if complete resection is possible with the spleen, gallbladder, pancreatic tail, and liver, registration is possible) 4. Patients with body mass index less than 18.5 (Kg/m2) 5. HER2-positive gastric cancer patients (HER2-positive is defined as 3+ or 2+ on immunohistochemical staining and HER2 gene amplification positive on in situ hybridization (ISH)). 6. Remnant gastric cancer patients 7. Patients unable to take anticancer drugs orally or patients with malabsorption syndrome 8. Patients with known deterioration within the last 3 years or other malignancies requiring active treatment. However, the exceptions are basal cell carcinoma of the skin, squamous cell carcinoma of the skin and thyroid carcinoma, and cervical epithelial cancer that have been treated for cure purposes 9. Patients confirmed to have active central nervous system (CNS) metastases and/or carcinoma meningitis. 10. Patients currently suffering from an active autoimmune disease who have received systemic treatment (ie, a disease modulator, corticosteroid, or immunosuppressant) within the last 2 years. However, replacement therapy (eg, thyroxine, insulin, physiological corticosteroid replacement therapy due to adrenal or pituitary insufficiency, etc.) is not recognized as systemic therapy. 11. Patients with clinically significant heart disease 12. Patients with more than 2 degrees of nervous system toxicity 13. Patients who are constantly taking the following drugs that change the pharmacological activity of capcitabine -Do not use the following drugs in combination with capecitabin as adverse events may increase: fluoropyrimidine anticancer drugs and antifungal drugs (e.g., fluorouracil, tegafur, doxyfluridine, capecitabine, flucytosine, etc.) -The following drugs may increase blood concentration due to S-1 and capecitabine, so be careful when administering them together: Phenytoin, Wafarin potassium 15. Patients who are pregnant or lactating, or who have a 2-year-old plan during the scheduled clinical trial period from the screening visit to the 120th day after the last dose of the test drug. 16. Patients with known history of human immunodeficiency virus (HIV) (HIV-1/2 antibody). 17. Patients with known active hepatitis B (eg, HBsAg positive and HBV DNA detected) or hepatitis C (Anti-HCV positive and HCV RNA [qualitatively] detected). 18. Patients who received live vaccine within 30 days prior to the scheduled initial dose of the study drug. Note: The seasonal flu vaccine is usually an inactivated flu vaccine and is acceptable; However, nasal influenza vaccines (eg Flu-Mist®) are attenuated live vaccines and are therefore not acceptable. 19. Other cases -In case of a history of infectious ulcers, fractures, severe surgery or injuries, or other serious medical problems that may cause damage to the patient's function within 28 days and make it difficult for the patient to receive treatment in the protocol. -Psychiatric or neurological condition or dementia that would make it difficult to understand and submit patient consent -Patien
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A possibility of termination surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year OS | — |
Countries
Korea, Republic of
Contacts
Public ContactSEUNGHO CHOI
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed