JPRN-jRCTs051180184已完成1 期
Biweekly TAS-102 with Bevacizumab combination study - BiTS Study
Kato Takeshi0 个研究点目标入组 44 人开始时间: 2019年3月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
Biweekly TAS-102 with BEV in combination for patients with mCRC shows promising antitumor efficacy and acceptable toxicity, and might represent a treatment option for patients with heavily treated mCRC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. written informed consent
- •2. age >= 20y
- •3. histologically proven colorectal adenocarcinoma with metastatic disease
- •4. prior treatment history including fluoropyrimidine, irinotecan, oxaliplatin and anti-EGFR (in case of RAS WT)
- •5. ECOG PS <2
- •6. capable oral intake
- •7. evaluable lesions on the basis of RECIST v1.1
- •8. adequate organ function
- •a. Hb >= 8.0 g/dL
- •b. Neutrophil >= 1500/ mm3
- •c. Plt >= 75,000/ mm3
- •d. T-Bil <= 1.5 md/dL
- •e. AST/ALT <=100IU/L (in case of liver metastasis <= 200 IU/L)
- •f. serum creatinine <= 1.5 md/dL
- •9. a woman who have no plan to get pregnant
- •10. with an appropriate mental capacity
排除标准
- •1. any of the following complication:
- •a. synchronous active malignancies other than carcinoma in situ or mucosal cancer
- •b. central nervous system metastases
- •c. active infection
- •d. uncontrolled ascites, pleural effusion, pericardial effusion
- •e. bowel obstruction, renal failure, liver failure,
- •f. uncontrolled DM
- •g. uncontrolled hypertension
- •h. symptomatic heart disease within 12 months
- •i. active gastrointestinal bleeding
- •j. uncontrolled HIV infection, HBV infection, HCV infection
- •k. immunodeficency
- •l. sever mental disorder
- •2. any of the following treatment:
- •a. thoracotomy, or intestinal resection within 4 weeks
- •b. chemotherapy within 1 week
- •c. extensive radiotherapy
- •d. investigational new drug within 1 week
- •3. history of TAS-102
- •4. grade 2 or more adverse events not recovered
- •5. transfusion within 7 days
- •6. urine dipstick for proteinuria more than +2
- •7. severe thrombosis or severe pulmonary disease
- •8. unhealed wound
- •9. hemorrhagic diathesis
- •10. pregnant and lactating females
- •11. patients judged by the investigator as unfit to be enrolled in the study
研究者
相似试验
已完成
2 期
TAS-CC4 Studycolorectal cancerJPRN-jRCTs031180424Yamada Takeshi45
已完成
不适用
Biweekly TAS-102 with Bevacizumab combination studyJPRN-UMIN000029198PO Epidemiological and Clinical Research Information Network(ECRIN)46
尚未招募
2 期
TAS-102 plus Bevacizumab combination as salvage therapy in elderly patients with metastatic colorectal cancer, phase 2 trialmetastatic colorectal cancerJPRN-UMIN000021664Tokushima University Hospital25
尚未招募
2 期
TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trialmetastatic colorectal cancerJPRN-UMIN000022437Teikyo University Chiba Medical Center20
已完成
2 期
TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancerColorectal CancerJPRN-UMIN000031790Surgical Oncology Association in Chiba (SOAC)45