drugset / Trial / NCT02023021

Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection

NCT02023021 ↗

Phase 2 Completed 80 enrolled Xian-Jun Yu
NaSingle-groupOpen-labelTreatment

Summary

Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than 5%. About 25% of patients have the opportunity for radically surgical resection when diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced overall survival for patients who have undergone surgery to remove their tumor. Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival and overall survival of metastatic pancreatic cancer patients. The present study is intended to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel as adjuvant chemotherapy in treating patients with pancreatic cancer after curative resection.

Timeline

Start
2014-01
Primary completion
2018-06
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 100 mg/m2 Intravenous