Pancreatic cancer
Conditions
Interventions
Qingyi Huaji Recipe combined with neoadjuvant chemotherapy group:Qingyi Huaji Recipe combined with neoadjuvant chemotherapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: ? Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma (other types); ? Physical condition score ECOG 0 to 2; ? Pregnant patients cannot participate in this study. Women of childbearing age were tested for serum ß-HCG. Women of childbearing age must use appropriate methods of contraception to minimize the risk of pregnancy throughout the study period and for 12 weeks after the last dose of study product; ? Patient organ function tests must meet the following laboratory parameters: neutrophils 1,500/Ul, hemoglobin > 8.0 gm/dL, platelets 100,000/uL, serum creatinine < 2.0 mg/dL, bilirubin < 1.5 mg/dL, and alanine aminotransferase < 3 times normal values; ? Age greater than 18 years; ? Expected postoperative survival = 3 months; ? Ability to comply with the study visit plan and other protocol requirements; ? Voluntary participation and signing of informed consent.
Exclusion criteria
Exclusion criteria: ? ECOG physical status score of 3-4; ? CNS damage or soft meningeal disease; ? Metastasis to distant sites; ? Other serious diseases or conditions, including congestive heart failure (New York Heart Association class III or IV), unstable angina pectoris, infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, and substance abuse; ? Known hypersensitivity to the components of the pancreas-cleansing formula or to albumin-bound paclitaxel or gemcitabine; ? Co-infected individuals who require intravenous antibiotic therapy; ? Pregnant or lactating women. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the treatment period of this trial and for 12 weeks after the last dose of study drug. Sexually active, fertile men who are not using effective contraception themselves if their partner is a woman of childbearing potential; ? Known neuroendocrine tumor of the pancreas; ? Past or concurrent cancers with primary foci or histology completely different from pancreatic cancer, except for cervical cancer in situ, previously treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer cured >5 years prior to enrollment is allowed; ? Inability to swallow herbal medicines or untreated malabsorption syndrome and unwillingness to take herbal medicines. ? Patients with poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with a 50% decrease in CA19-9;Quality of life; | — |
Countries
China
Contacts
Public ContactYu Xianjun
Fudan University Shanghai Cancer Center
Outcome results
None listed