JPRN-jRCTs021200003
Recruiting
Phase 1
Phase I, II study of neoadjuvant chemotherapy with gemcitabine and nab-paclitaxel for resectable pancreatic cancer - APCS-01
Ishido Keinosuke0 sites30 target enrollmentMay 8, 2020
Conditionspancreatic ductal cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- pancreatic ductal cancer
- Sponsor
- Ishido Keinosuke
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pathologically adenocarcinoma or adenosquamous carcinoma is confirmed.
- •2\. No distant metastasis except for the positive case of intraoerative abdominal cytology.
- •3\. Resectable pancreatic cancer according to the Japan Classification of pancreatic cancer 7th edition.
- •4\. Patients who are tolerable for radical surgery,
- •5\. Patients who had not treated for pancreatic cancer.
- •6\. Over 20 y.o.
- •7\. ECOG PS, 0\-1
- •8\. In cases with obstructive jaundice, proper drainage is performed.
- •9\. Cases in which functions of major organs (bone marrow, liver, kidney, lung, etc.) are retained.
- •10\. The informed consent has been obtained from the patient concerning the participation in the document.
Exclusion Criteria
- •1\. Patients who had treated with gemcitabine and nab\-paclitaxel.
- •2\. Patients who are judged that R2 resection is anticipated.
- •3\. Severe diarrhea
- •4\. Patients who have sever ascitis fluid and pleural effusion.
- •5\. Patients who have active malignant disease but pancreatic cancer.
- •6\. Patients who have sever co\-morbidity.
- •7\. Patients who have active infection except type B and C viral hepatitis.
- •8\. Patients who have either significant abnormality of ECG or sever heart disease.
- •9\. Patients who have sever psychiatric disease.
- •10\. Pregnant women, nursing women and cases who are likely to be pregnant or willing, men who wish to be pregnant by partner.
Outcomes
Primary Outcomes
Not specified
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