KCT0005303尚未招募未知
Phase 2 trial of rechallenge high-dose irinotecan with UGT1A1 genotype in refractory metastatic colorectal cancer
ational Cancer Center0 个研究点目标入组 37 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 37
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Those who voluntarily and in writing consent to participate in this study
- •2. Male and female patients over 19 years old
- •3. Patients with histologically confirmed metastatic or recurrent colorectal cancer
- •-Patients who received second or later-line chemotherapy including 5-fluorouracil, oxaliplatin, and irinotecan as anticancer drugs. Targeted therapies and immunooncology drugs are also permitted.
- •-Adjuvant chemotherapy is considered as primary chemotherapy if relapse is confirmed within 6 months of completion.
- •-Patients who have had a complete or partial response or have had stable lesions for more than 24 weeks through chemotherapy, including previous irinotecan.
- •-Patients whose imaging progress has been confirmed during chemotherapy including irinotecan or within 6 months after the end of chemotherapy
- •-Patients 12 weeks or more after the last dose of chemotherapy, including irinotecan.
- •4. Patients with Eastern cooperative oncology group (ECOG) performance status = 1
- •5. Patients with an expected survival period of 12 weeks or more
- •6. Patients with evaluable lesions in Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
- •7. Patients whose proper hematologic function, kidney and liver function are confirmed by the following criteria
- •-White blood count (WBC) of 3,000/µL or more
- •-Absolute neutrophil count (ANC) of 1,000/µL or more
- •-Platelet count is over 100,000/µL
- •-Hemoglobin count is over 9.0 g/dL
- •-Bilirubin is 1.5 times or less of the upper limit of normal (ULN)
- •-Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are 3 times or less of ULN (5 times or less of ULN if liver metastasis is present)
- •-Serum creatinine is 1.5 times less than ULN
- •8. A person who understands the contents of the clinical trial, is cooperative in the trial, and is considered to be able to participate until the end of the study.
排除标准
- •1. Pregnant or lactating women
- •2. Patients who received chemotherapy or immunotherapy within 2 weeks prior to screening
- •3. Patients undergoing major surgery or radiation therapy within 4 weeks prior to screening
- •4. You have a history of malignancy within 3 years of registration. However, basal or squamous cell skin cancer, cervical epithelial tumor, breast epithelial cancer, or prostate-specific antigen <0.01 ng/mL, except for prostate cancer treated with surgery or RT.
- •5. Patients with symptomatic central nervous system metastases (except for the case where systemic corticosteroid administration was stopped at least 4 weeks prior to baseline and neurologically stable for 4 weeks or more)
- •6. Significant cardiovascular disease, including congestive heart failure of the New York Heart Association Grade III or IV, myocardial infarction within 6 months of enrollment, unstable angina, poorly controlled heart arrhythmias, or stroke within the past 6 months.
- •7. Child-Pugh B or C patients with evidence of cirrhosis. In the case of HBV or HCV-related chronic hepatitis or cirrhosis Child-Pugh A, if the liver function is stably maintained through drug treatment, it may be registered in a clinical trial.
- •8. Other uncontrolled concomitant medical conditions, including systemic fungal, bacterial, or viral infections
- •9. People with the following diseases or conditions
- •-Chronic inflammatory bowel disease
- •-Patients with severe intestinal palsy and intestinal obstruction requiring interventional treatment
- •-Patients with interstitial pneumonia or pulmonary fibrosis
- •-Patients with large amounts of ascites and pleural effusion
- •-Patients with diarrhea
- •-Dialysis patients
- •-Patients with a history of hypersensitivity to irinotecan or its components
- •-Patients receiving atazanavir sulfate or St. John's wort
- •10. A person deemed inappropriate by the researcher
研究者
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