Status:
UNKNOWN
Neoadjuvant Nab-Paclitaxel and S-1 in Borderline Resectable Pancreatic Cancer
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Borderline Resectable Pancreatic Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline re...
Eligibility Criteria
Inclusion
- Patients have good compliance, can understand the research process of this study, and sign a written informed consent
- Patients with pathologically confirmed pancreatic adenocarcinoma.
- Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
- Patients with borderline resectable pancreatic cancer ( NCCN Version 1，2019 criteria).
- ECOG PS 0-1;
- Tumor size is measurable according to RECIST1.1 criteria
- Expected survival over 3 months;
- Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
- Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
- No contraindications to the use of S-1 and nab-paclitaxel.
Exclusion
- ≥ Grade 2 existing peripheral neuropathy;
- Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
- Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
- Not able to take medicine orally.
- Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
- Participation in other clinical trial within 30 days before the first dose of the drug;
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03850769
Start Date
May 1 2019
End Date
April 1 2022
Last Update
March 10 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China