KCT0003564
Completed
未知
A Phase 2 Study to Evaluate the Safety and Efficacy of nab®-Paclitaxel plus Gemcitabine in Korean Patients with Metastatic and Advanced Pancreatic Ductal Adenocarcinoma
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Samsung Medical Center
- Enrollment
- 111
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A subject will be eligible for inclusion in this study only if all of the following criteria are met:
- •1\.Histologically or cytologically confirmed metastatic (cohort 1\) or locally advanced unresectable (cohort 2\) pancreatic ductal adenocarcinoma (Islet cell neoplasms or neuroendocrine carcinomas are excluded)
- •2\.Locally advanced unresectable pancreatic cancer according to radiographic criteria (CT or MRI scans) or exploration:
- •(1\) Superior mesenteric vein and portal vein: occlusion, thrombosis, or encasement extending several centimeters
- •(2\) Superior mesenteric artery: tumor abutment \> 180 degrees or thrombosis of artery
- •(3\) Celiac axis: abutment or encasement of the celiac axis
- •(4\) Lymph nodes: involvement
- •3\. \= 19 years of age at the time of signing the informed consent document
- •4\.ECOG 0\-1
- •5\.At least one measurable lesion according to Recist v1\.1
Exclusion Criteria
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1\.Subject has known symptomatic brain metastases. (Subjects with adequately treated brain or CNS metastases are and have been stable may be included)
- •2\.Any metastasis for patients with locally advanced disease (cohort 2\)
- •3\.History of malignancy in the last 5 years.
- •4\.Breast\-feeding or pregnant female
- •5\.Patients with plastic biliary stent (Metal biliary stents are allowed.)
- •6\.Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- •7\.Subject with known history of HIV or know history of active hepatitis B, or hepatitis C and are currently serologically positive with evidence of active chronic active hepatitis.
- •8\.Subject has undergone major surgery within 4 weeks prior to Cycle 1 Day 1 of treatment in this study.
- •9\.Subject who experienced a recent myocardial infarction, including severe/unstable angina pectoris, coronary/peripheral artery bypass graft, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, significant or uncontrolled cardiovascular disease CHF, and cerebrovascular accident or transient ischemic attack, or seizure disorder in the past year.
Outcomes
Primary Outcomes
Not specified
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