A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer
The investigators design a phase II/III trial to compared Mirtazapine plus gemcitabine with
gemcitabine in metastasis pancreatic cancer. The investigators planed to enroll 33 patients
for each arm after randomization.
The inclusion criteria included:
1. Patients shall have normal organic function such as liver function, Cardiac function
and renal function.
2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree
of depression and anxiety scale. Only patients with definite depression and/or anxiety
will be considering participating this trial.
3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
4. Patients should be expected to live no shorter than 1.5 months
The investigators will evaluated the quality of life by SF-36 scale as primary outcome. The
second outcomes include anxious and depression scores, objective response rate, progress
free survival, overall Survival and chemotherapy induced nausea and vomiting.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
quality of life
primary outcome is the quality of life evaluated by SF-36 scale
up to 3 years
Yi Ba, MD, PHD
Tianjin Medical University Cancer Institute and Hospital
China: Food and Drug Administration