JPRN-jRCT2041210056招募中1 期
Phase I/II investigator-initiated clinical trial of MIKE-1 with Gemcitabine and Nab-paclitaxel combination therapy for unresectable pancreatic cancer
Kawashima Hiroki0 个研究点目标入组 55 人开始时间: 2021年8月19日最近更新:
适应症
试验速览
- 阶段
- 1 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 <= 79age old（—）
- 性别
- All
入选标准
- •1. Patients with unresectable pancreatic cancer who are histologically or cytologically diagnosed as adenocarcinoma based on the 7th edition of the Pancreatic Cancer Treatment Protocol and meet the following criteria.
- •Patients who have not received any anticancer therapy (radiation therapy, chemotherapy, immunotherapy, surgery, or investigational therapy) for this disease.
- •2. Patients who are between 20 and 79 years of age at the time of consent.
- •3. Patients with at least one measurable lesion based on RECIST ver 1.1 in the primary pancreatic lesion confirmed by contrast-enhanced CT at the screening.
- •4. patients who are expected to survive for at least 12 weeks after the start of treatment.
- •5. patients who can understand the contents of this study and can give written consent.
- •6. patients with ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1
- •7. Patients who meet the criteria in blood tests within 7 days before enrollment and whose organ functions are preserved.
- •8. outpatients who can go to the hospital.
- •9. Patients who can swallow or continue to take oral medications.
- •10. for women of childbearing potential, patients who can use contraception for at least 30 days before the start of study treatment, during the study period, and for at least 2 years after the end of treatment.
- •11. patients who can undergo biopsy from pancreatic cancer within 28 days before the start of the study treatment and 8 weeks after the start of the study treatment (Day 57: acceptable range: 7 days)
排除标准
- •1. Patients with any of the following complications
- •Patients with poorly controlled heart disease (congestive heart failure, myocardial infarction, or unstable angina within 1 year before enrollment, arrhythmia requiring treatment, etc.)
- •Poorly controlled diabetes or hypertension
- •Active autoimmune disease requiring systemic administration of steroids or immunosuppression therapy
- •Interstitial pneumonia or pulmonary fibrosis (patients with current grade 2 or higher)
- •2. patients who have received other clinical trial drugs or products (excluding existing chemotherapeutic agents and placebo drugs) within 4 weeks before enrolment.
- •3. Patients with confirmed brain metastasis (confirmed by head CT or MRI if the patient has symptoms of brain metastasis)
- •4. Patients with ascites or pleural effusion requiring drainage.
- •5. patients who fall under any of the following
- •HBs antigen positive
- •HCV antibody positive and HCV-RNA positive
- •HIV antibody positive
- •6. Patients with Grade 2 or higher peripheral sensory or motor neuropathy
- •7. Patients with multiple cancers (multiple cancers are defined as simultaneous multiple cancers and metachronous multiple cancers with disease-free survival of 5 years or less. lesions equivalent to carcinoma in situ or intramucosal carcinoma that are considered curable by local treatment are not included in multiple cancers)
- •8. Patients who have undergone surgery (excluding diagnostic biopsy and review laparoscopy) within 4 weeks before enrollment.
- •9. Patients with bleeding disorders or coagulation disorders that preclude the safe biopsy under EUS (e.g., significant intratumoral bleeding, coagulation disorders, history of bleeding disorders, or complications).
- •10. patients with a history of allergy to the trial drug, combination chemotherapy, its additives, or vitamin A products.
- •11. Patients requiring anticoagulant medication
- •12. Patients with cerebral infarction, pulmonary infarction, other arterial or venous thrombosis or its sequelae with clinical symptoms
- •13. Patients with gastrointestinal disorders that may affect the absorption of the investigational drug.
- •14. female patients who are pregnant or breastfeeding (unless breastfeeding is discontinued and not resumed)
- •15. male patients whose sex partner is a woman who wishes to become pregnant
- •16. patients with vitamin A overload
- •17. patients receiving vitamin A preparations or regularly using vitamin A-containing supplements (patients can be enrolled if the administration is discontinued at the time of obtaining consent)
- •18. other patients deemed inappropriate by the investigator or sub-investigator
研究者
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