KCT0004670已完成未知
A Multicenter, Open-label, Phase I/II Clinical Trial of Intraperitoneal Paclitaxel and Oral S-1 and Intravenous Oxaliplatin Combination Therapy in Patients with Advanced or Recurrent Gastric Cancer with Peritoneal metastasis
Myungmoon Pharm0 个研究点目标入组 53 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 53
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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) < 15×109/L, Platelet < 100×109/L,
- •? Hemoglobin (Hb) 10 10 g/?
- •? AST > 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 (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
研究者
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