pancreatic cancer
Conditions
Interventions
Experimental group:Traditional Chinese Medicine,TCM
Control group:placebo
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: [1] Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma; [2] Patients with newly diagnosed inoperable advanced pancreatic cancer or patients with recurrent metastasis after pancreatic cancer; [3] Age>=18 years and 1,500/ul, hemoglobin > 8.0 gm/dL, platelets > 100,000/uL, serum creatinine < 2.0 mg/dL, bilirubin < 1.5 mg/dL, alanine aminotransferase < 3 times normal; [7] Patients with bone metastases are allowed to receive bisphosphonate therapy at the same time; [8] Able to understand and sign a written informed consent document; [9] Those who are expected to survive for more than 3 months
Exclusion criteria
Exclusion criteria: 1) Previously received neoadjuvant adjuvant chemotherapy; 2) Previously received radiotherapy for pancreatic tumours; 3) Central nervous system disease; 4) Other serious diseases or conditions, including congestive heart failure (New York Heart Association class III or IV), unstable angina, history of myocardial infarction within the past 6 months, severe arrhythmia, human immunodeficiency virus infection, any psychological disorders, history of substance abuse, etc.; 5) Co-infection required intravenous antibiotic treatment; 6) Pregnant, breastfeeding women or women of reproductive age who were unwilling or unable to take measures for contraception during the entire treatment period of this trial and for the first 12 weeks of follow-ups; or if the partner of a women of reproductive age who were sexually active and fertile men that refused to take effective contraceptive measures; 7) Known ampullary carcinoma, or pancreatic neuroendocrine tumour, acinar cell carcinoma, intraductal papilloma and other non-pancreatic ductal adenocarcinomas; 8) History of a primary tumour of other origin or any histological malignancies within the recent 3 years, except for treated basal cell carcinoma, cervical carcinoma in situ, and superficial bladder tumours (Ta, Tis, and T1); any cancer that has been cured for more than three years prior to the enrollment to this present trial was allowed for inclusion; 9) Any known allergy to components of TCM-001 or gemcitabine; 10) Those who were unable to swallow CM, who had untreated malabsorption syndrome, or were unwilling to take CM; 11) Patients with poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Potential predictive biomarkers; | — |
Countries
China
Contacts
Public ContactMeng Zhiqiang
Fudan University Shanghai Cancer Center
Outcome results
None listed