Spots Global Cancer Trial Database for Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

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Trial Identification

Brief Title: Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

Official Title: A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

Study ID: NCT03929094

Conditions

Metastatic Pancreatic Cancer

Interventions

Paclitaxel for Injection（Albumin Bound）

Gemcitabine

Study Description

Brief Summary: This is a single arm, open-label Phase II clinical trial to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients with metastatic pancreatic cancer.

Detailed Description: While GT (Gemcitabine + Nab-paclitaxel) is one of the preferred regimens for metastatic pancreatic cancer, we have yet to determine the optimum number of cycles for GT treatment regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) and gemcitabine 1000 mg/m\^2 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. The safety and efficacy of each group will be assessed through ORR, PFS, OS and adverse effects as graded by CTC-AE 5.0.