JPRN-jRCT2041210056
Recruiting
Phase 1
Phase I/II investigator-initiated clinical trial of MIKE-1 with Gemcitabine and Nab-paclitaxel combination therapy for unresectable pancreatic cancer
Kawashima Hiroki0 sites55 target enrollmentAugust 19, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with untreated, non-resectable pancreatic cancer
- Sponsor
- Kawashima Hiroki
- Enrollment
- 55
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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