KCT0007269尚未招募未知
Phase ? Study of Azacitidine Plus Oxaliplatin in Subjects with Recurrent and Metastatic Epstein-Barr virus-associated Gastric cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 32
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 o Limit（—）
- 性别
- All
入选标准
- •1. Patients with recurrent, metastatic gastric cancer who have been confirmed histologically or cytologically. Confirmation is made by integrating histopathological information in the context of clinical and radiation information.
- •2. EBV-positive gastric cancer confirmed by EBV-encoded RNA detection through in situ hybridization. (Reference)1
- •3. Patients who have previously been exposed to at least three drugs of the Platinum, fluoropyrimidine, paclitaxel, docetaxel, irinotecan, TAS-102, or ramucirumab family, and are treated with tertiary or higher treatment.
- •4. He has received chemotherapy more than twice in the past. (Above tertiary treatment)
- •5. Patients who are not pregnant (positive for human chorionic gonadotropin test) or breastfeeding
- •6. The blood counts of the following matters must be satisfied. (Results obtained before 14 days of random assignment)
- •o Absolute neutrophil (ANC) =1.5 x 109/L;
- •o Platelet count =100,000/mm3 (100×109/L);
- •o Hemoglobin (Hgb) = 9 9 g/dL.
- •7. The blood chemistry of the following matters must be satisfied. (Results obtained 14 days before random assignment)
- •o AST (SGOT), ALT (SGPT) = 2.5 × upper limit of normal range (ULN)
- •If you have liver metastasis = 5 x ULN.
- •o Total bilirubin = ULN
- •o Creatinine = ULN
- •8. Patients with ECOG PS = 2.
- •9. A patient who voluntarily agrees to participate in the study and agrees in writing to the consent form prior to participating in any research-related act.
- •10. Patients recovered from toxicity of previous therapy (grade 2 or lower alopecia associated with previous treatment or level 2 or lower toxicity that does not pose a continuous safety risk based on the investigator's discretion)
排除标准
- •1. Patients with a history of cancer in the last five years. Patients with in-place carcinoma or basal or squamous cell cancer of the skin are eligible to participate. In the case of other cancers, patients who have been treated well with surgery alone or in combination with surgery and radiation therapy, and who have not had a disease continuously for at least 5 years, can participate.
- •2. Patients with uncontrolled infections (bacteria, viruses, fungi)
- •3. Patients who have or are currently infected with unregulated HIV, unregulated hepatitis B or hepatitis C
- •4. Patients who are allergic to or overreacting to azathidine or oxaliplatin. Patients with symptoms mentioned in the taboo or precautions.
- •5. High-risk cardiovascular patients (including patients who recently underwent coronary stent procedures or developed myocardial infarction within the last 6 months)
- •6. Patients with a history of peripheral arterial disease (e.g., limp, Leo Buerger's)
- •7. Patients with neuropathic grade 2 or higher
- •8. Sexually active women (pregnant) and men who have no intention of performing contraception during clinical trials and up to 6 months after discontinuation of clinical trials
研究者
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