None listed
Conditions
Interventions
Drug : In the first phase clinical trial, SOX is administered at a fixed dose in the first cycle of the bottle chemotherapy and the IP Paclitaxel capacity starts at 40 m2 and follows the standard 3+3
Sponsors
Myungmoon Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria (1) Patients aged 20 years and under 80 years old (2) Patients whose ECOG performance is equal to 0 or 1; (3) Patients with progressive or recurrent carcinoma of the boundary of stomach or stomach esophagus accompanied by histologically or imagingally identified peritoneal pancreas (including the positive of peritoneal cytogen); (4) Patients who have signed a written consent form approved by the Agency's Research Ethics Review Committee to take part in this study after receiving a full explanation of the purpose and content of the test prior to their participation in the test.
Exclusion criteria
Exclusion criteria: Exclusion criteria - Related to methodology (1) Patients who have undergone surgery or chemotherapy for other long-term primary cancer within the last five years (excluding completely cured basal cell or squamous cell skin cancer and intraepithelial cancer of the cervix) (2) Metastatic gastric adenocarcinoma or gastroesophageal borderline adenocarcinoma with confirmed HER2 overexpression (IHC 3+ or IHC 2+ and ISH positive) in primary tumors or metastatic lesions (3) Persons who have participated in other clinical trials and administered other clinical trial medications within 30 days prior to registration of this trial; (4) Within the last 6 months, any of the following applies: ? myocardial infarction ? Severe/unstable angina ? Coronation/peripheral artery bypass ? NYHA class III or IV congestive heart failure ? Stroke or transient ischemia attack (5) A person with previous uncontrolled seizures, central nervous system, or psychological disabilities who is clinically significant enough to disallow the consent of the study subjects and interfere with oral medication (6) Uncontrolled active infection or sepsis (7) Deep venous thrombosis within 4 weeks prior to start of trial recruitment (8) Severe acute or chronic illness that may reduce the patient's ability to participate in clinical trials or make it difficult to interpret clinical trial results (9) Those who have not fully recovered from symptomatic surgery, such as bleeding/intestinal obstruction, etc : Except for Open & Close, Staging Laparoscopic, or Biopsy only (10) A person who has received a palliative, postoperative adjuvant chemotherapy, or preoperative chemotherapy and/or radiation and/or immunotherapy for the treatment of stomach cancer currently being treated within the last month; (11) Those who are resistant to oral administration or have poor absorption. A person whose lack of physical completeness in the upper part of the gastrointestinal tract has not been recovered or who has an absorption disorder that may affect the absorption of oral drugs. People with intestinal obstruction, chronic inflammatory bowel disease, or extensive small intestine resection and other diseases that limit drug absorption. (12) Severe tumor bleeding of Grade 2 or higher (13) Among childbearing patients, those who do not agree to use generally accepted effective contraception for at least six months after the end of clinical trial drug administration. The definition of "effective contraception" is based on the tester's judgment. (14) Positive pregnancy test results in pregnant women, lactating women, and childbearing women. - Related to clinical trial medication (1) Inadequate bone marrow and organ function: ? Absolute neutrophil count (ANC) 2.5 ×ULN, ALT > 2.5 ×ULN, ALP > 2.5 ×ULN, ? Total bilirubin > 1.5 × ULN, ? Serum Cr > 1.5 × ULN [Creatinine Cleaning Rate (Ccr) is calculated using the Cockcroft-Gault formula or by collecting urea for 24 hours. Ccr <Except for patients with 60 mL/min] (2) Peripheral neuropathy with Grade 22 (NCI CTCAE v4.03) (3) Absence of deep tendon reflex (DTR) (4) Grade 22 of hearing loss patients (NCI CTCAE v4.03) (5) Past history of hypersensitivity to clinical trial drugs (Paclitaxel, Oxaliplatin, TS-1) (6) Those receiving warfarin or other coumarin-based anticoagulant therapy (7) a person under immunosuppressive therapy (8) an infectious agent (9) an epil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| imaging for tumor response evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| general condition | — |
Countries
Korea, Republic of
Contacts
Public ContactHAM SEONWOOK
Koera University Guro Hospital
Outcome results
None listed