JPRN-jRCT1051180117招募中2 期
Phase II study of TAS-102 plus bevacizumab as maintenance therapy after induction chemotherapy with bevacizumab, oxaliplatin, and fluoropyrimidine in patients with metastatic colorectal cancer - Switch Maintenance Study
emura Mamoru0 个研究点目标入组 55 人开始时间: 2019年3月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
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 ot applicable（—）
- 性别
- All
入选标准
- •1) Historical or cytological documentation of adenocarcinoma of the colon or rectum
- •2) First line chemotherapy and non-resectable advanced colorectal cancer. If patients were performed adjuvant chemotherapy, the period until first line chemotherapy has to be at least 6 months.
- •3) Male or female patients >= 20
- •4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- •5) Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements conducted within 14 days of starting study treatment:
- •1. Absolute neutrophil count >= 1500 /mm3
- •2. Hemoglobin >= 9.0 g/dl
- •3. Platelet >=100000 /mm3
- •4. Total bilirubin <=1.5 ml/dl
- •5. AST and ALT <=100 IU/l
- •6. Creatinine <= 1.5 mg/dl
- •6) Life expectancy of at least 90 days.
- •7) Patients must have measurable or non measurable disease according to RECIST version 1.1
- •8) Induction chemotherapy was done by CapeOX+Bevacizumb or FOLFOX+Bevacizumab. Except the induction therapy done by other approved standard therapies which include irinotecan or anti-EGFR drug.
- •9) Conduct a first line induction chemotherapy with bevacizumab, oxaliplatin, and fluoropyrimidine. Induction therapy will be stop systematically for 3 to 4 months then; the chemotherapy switch to TAS-102 plus bevacizumab; expected oxaliplatin dose is 610 to 680 mg/M2.
- •10) Confirmed the disease control; CR/PR/SD by each image after induction therapy.
- •11) Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent.
排除标准
- •1) Prior treatment with TAS-102 and Bevacizumab.
- •2) Previous or concurrent cancer that is distinct in primary site or histology form colorectal cancer within 1 years prior to EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta, Tis and T1].
- •3) Major surgical procedure within 28 days before start of study medication.
- •4) Pregnant or breast-feeding patients. Woman of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
- •5)Congestive heart failure >=NYHA class 2.
- •6) Unstable angina, new-onset angina. Myocardial infarction less than 6 months before start of study medication.
- •7)Uncontrolled hypertension.
- •8) Pleural effusion or ascites with dyspnea higher than CTCAE v4.0 grade 2.
- •9) Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication.
- •10) Known history of HIV infection, or chronic hepatitis B or C.
- •11) Symptomatic metastatic brain or meningeal metastasis.
- •12) Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >= CTCAE v4.0 Grade 3 within 4 weeks of start of study medication.
- •13) Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
- •14) Persistant proteinuria of CTCAE v4.0 Grade 3 or higher.
- •15) Patients unable to swallow oral medications.
- •16) Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- •17) Non-healing wound, ulcer, or bone fracture.
- •18) Unsolved toxicity higher than CTCAE v4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity <= Grade 2.
- •19) A responsible doctor has confirmed the candidate should be excluded from this study.
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