JPRN-jRCTs011190006进行中（未招募）2 期
A non-randomized multicenter prospective phase II study evaluating efficacy and safety of FOLFIRI+aflibercept as second-line chemotherapy in patients with colorectal cancer resistant to anti-EGFR chemotherapy (HGCSG1801) - HGCSG1801
Komatsu Yoshito0 个研究点目标入组 41 人开始时间: 2019年11月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
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
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1. Age 20-85 years old
- •2. Histologically confirmed colorectal adenocarcinoma
- •3. ECOG PS 0 or 1
- •4. Documented disease progression 90days or more after the start of 1st-line chemotherapy containing anti-EGFR antibodies, oxaliplatin and fluoropyrimidines.
- •5. Adequate major organ and hematological functions within 14days before registration
- •6. Expected survival time 3 months or more at the registration
- •7. With documented informed consent
排除标准
- •1. Symptomatic CNS invasion and/or brain metastases
- •2. Uncontrollable infections
- •3. Uncontrollable diarrhea, anorexia or nausea
- •4. Uncontrollable hypertension
- •5. Symptomatic plural effusion or ascites
- •6. Inability of oral intake
- •7. Radiation to all lesions
- •8. UGT1A1 *6 homo, *28 homo, or *6 and *28 double hetero
- •9. History of other malignancies within 5 years (except for curative resection of carcinoma in situ)
- •10. Pregrant women
- •11. Irinotecan-containing regimen as 1st-line therapy
- •12. Following status:
- •Gastrointestinal or abdominal inflammations
- •Gastrointestinal or other bleeding
- •Hemorrhagic diathesis, coagulopathy, or treated with anticoagulants
- •Thromboembolism
- •No wound healing from major surgery
- •13. Administration of aflibercept-containing medications
- •14. Dihydropyrimidine dehydrogenase deficiency
- •15. Interstitial pneumonia or pulmonary fibrosis
- •16. Participation in the clinical trial is determined as unsuitable
研究者
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