KCT0009110尚未招募Unknown
Intraperitoneal Paclitaxel Plus Systemic Chemotherapy Versus Systemic Chemotherapy Alone for Advanced or Recurrent Gastric,Gastro-oesophageal Junction Adenocarcinoma with Peritoneal Metastasis a multicenter, randomized, open-label, phase 3 trial (PIPS-GC 003)
Koera University Guro Hospital0 个研究点目标入组 117 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 117
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •Selection criteria
- •(1) 19 to 85
- •(2) Patients with ECOG performance 0 or 1
- •(3) Patients with advanced or recurrent adenocarcinoma at the gastroesophageal border with histologically (including positive cytology) or imagingly confirmed peritoneal metastasis (imagingly suspected peritoneal metastasis is confirmed by biopsy and cytology at the time of diagnostic laparoscopy)
- •(4) Patients with sufficient bone marrow/hepatic/hepatic/hepatic function within 2 weeks of clinical trial initiation
- •? ANC >1,500/uL
- •? Hemoglobin > 9.0g/dlL (number reachable by transfusion in case of tumor bleeding)
- •? Platelet > 100,000/uL
- •? Total bilirubin < 1.5* normal upper limit (UNL)
- •? AST/ALT, ALP < 2.5* Normal upper limit
- •? Creatinine < 1.5mg/dL
- •(5) A patient who has signed a written consent form approved by the Institutional Research Ethics Review Committee to participate in this study at his/her free will prior to participating in the test after hearing sufficient explanation of the purpose and content of the test
排除标准
- •Exclusion criteria
- •(1) Patients who have undergone surgery for other organ primary cancer or have received chemotherapy or radiation therapy within the last 5 years (excluding complete basal or squamous cell skin cancer and intraepithelial cancer of the cervix)
- •(2) Patients with HER-2 positive at primary tumor or metastatic lesion (However, patients with peritoneal metastasis due to recurrence during Herceptin treatment after being diagnosed with HER-2 positive gastric cancer can participate)
- •(3) Patients with active viral infection (HIV, HBV, HCV; however, patients with HBs Ag in safe phase can be enrolled)
- •(4) A person who participates in another clinical trial and administers another clinical trial drug within 30 days prior to the registration of this trial
- •(5) Patients with a history of the following medical conditions within the last six months
- •myocardial infarction
- •severe/unstable angina
- •coronary/terminal arterial bypass
- •congestive heart failure of NYHA class III or IV
- •stroke or transient ischemic attack
- •a non-hemostatic wasting disease
- •sepsis caused by active infection
- •deep vein thrombosis
- •Peripheral neuropathy with Grade = 2 (NCI CTCAE v.5.0)
- •Hearing Impaired Patients with Grade = 2 (NCI CTCAE v.5.0)
- •People receiving anticoagulant therapy such as warfarin or other coumarin series
- •a person on immunosuppression therapy
- •a patient with interstitial pneumonia
- •Those with previous uncontrolled seizures, central nervous system or psychological disorders who have difficulty understanding or agreeing to the study or difficulty in accurately administering oral medications
- •A person currently receiving a combination of inducer, inhibitor, and substrate of cytochrome P4502A6
- •Drugs that inhibit CYP2C8 or CYP3A4 (e.g., ketoconazole and other amidazole antifungals, erythromycin, fluoxetine, zemphibrozyl, clopidogrel, cimetidine, ritonabi)
- •Uh, those who are receiving rifampicin, carbamazepine, phenytoin, epavirens, and nephinavir) or induced medications (e.g., rifampicin, carbamazepine, epavirens, and nevirapine)
- •(6) Patients who are judged to find it difficult to inject and maintain intraperitoneal chemotherapy without multiple drainage due to uncontrolled ascites during chemotherapy
- •(7) A person who has adhesions that make it difficult to inject anti-cancer drugs in the abdominal cavity due to the previous surgical history or medical history (peritoneal permeability, etc.)
- •(8) A person who has received chemotherapy including 5-fu + platin for adjuvant or conventional treatment of gastric cancer or gastric cancer peritoneal metastasis within the last 6 months
- •(9) Treatment of chemotherapy and radiation therapy or immunotherapy other than 5-fu + platin or S-1 series for adjuvant or conventional treatment of gastric cancer or gastric cancer peritoneal metastasis within the last 1 month
- •a person who has received
- •(10) Patients who have not fully recovered from surgery to relieve bleeding or intestinal obstruction due to gastric cancer (patients with eating disorders, white blood cells or CRP, procalcitonin, etc.)
- •(11) Pregnant women, nursing mothers, or women of childbearing age are positive for pregnancy test results
- •(12) Among the patients of childbearing age, agree to use generally accepted effective contraception for the duration of clinical trial drug administration and for at least six months after the end of clinical trial drug administration
- •a patient who doesn't lose.
- •(13) History of hypersensitivity to
研究者
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