patients with unresectable advanced or recurrent pancreatic cancer
Conditions
Interventions
gemcitabine and nab-paclitaxel therapy (standard treatment) group Observation period: 8 weeks
gemcitabine and nab-paclitaxel therapy with oral administration of TJ-3020 group Observation period: 8
Sponsors
Nagoya University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient diagnosed with unresectable advanced or recurrent pancreatic cancer 2) Patient who receive nab-paclitaxel and gemcitabine therapy 3) Estimated overall survival>=3months 4) ECOG-PS 0 or 1 5)Main organs function test almost within normal range: (a)WBC>=3,500/mm3, <=12,000/mm3 (b)Neutrophil>=1,500/mm3 (c)Platelet>=100,000/mm3 (d)Hemoglobin>=9.0g/dl (e)AST, ALT<=100IU/l (f)Total bilirubin<=2.0mg/dl,In biliary drainage cases<3.0mg/dl (g)Creatinine<=1.2mg/dl 6) Age>=20 years old 7) Informed concent was obtained.
Exclusion criteria
Exclusion criteria: 1) Patients who have allergies to traditional Chinese medicine 2) Patients with mental disorder or severe co-morbidity such as heart failure, renal failure, or bowel obstruction 3) Patients with pregnancy 4) Patients with intorerable of oral medications 5) Patients with active cancer of other organs 6) Patients who are judged inappropriate for the study responsible doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of fatigue and malaise by Cancer Fatigue Scale (CFS) | — |
Countries
Japan
Contacts
Public ContactSuguru Yamada
Nagoya University, Graduate School of Medicine Gastroenterorogical Surgery (Hepato-biliary Pancreatic Surgery)
Outcome results
None listed