Status:
UNKNOWN
Neoadjuvant Nab-Paclitaxel and S-1 in Resectable Pancreatic Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
There were limited data for nab-paclitaxel and S-1 in pancreatic cancer. To explore the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with resectable pancreatic cance...
Eligibility Criteria
Inclusion
- Signed informed-consent form;
- Treatment-naive PDAC with histological or cytological diagnosis;
- Resectable pancreatic cancer stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions;
- Age≥18 years old and ≤70 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- BMI≥18.5 and NRS2002score\<3;
- Expected survival over 3 months;
- Spared organ function satisfying the following laboratory data:leucocyte≥3.0x109/L,neutrophils≥1.5x109/L, hemoglobin≥ 9g/dL, platelets ≥100x109/L, total bilirubin ≤ 1.5 ULN; AST and ALT≤ 2.5 ULN; serum creatinine≤1.5ULN; PT and INR≤ 2.5 ULN;
Exclusion
- Severe Impaired organ functions;
- Patients who had surgeries, chemotherapy or other treatments before inclusion;
- Pregnant women or lactating women;
- Ineligible by the discretion of the investigator.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04808687
Start Date
March 1 2021
End Date
February 1 2024
Last Update
March 22 2021
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 30000