Pancreatic cancer
Conditions
Interventions
Treatment arm:Huang Bai pellets+S-1
Sponsors
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Patients with metastatic pancreatic ductal adenocarcinoma who have a pathologically or histologically confirmed TNM staging of III (inoperable) or IV (metastatic), or who have a clinical diagnosis that can be evaluated after careful discussion by the MDT in combination with medical history, clinical manifestations, laboratory tests and imaging examinations. And the diagnosis related to the evidence of damp-heat accumulation and internal stasis of blood was met. (2) Received treatment with a gemcitabine-containing regimen before the study was conducted and developed tumor progression or further metastasis. Gemcitabine chemotherapy must have been completed at least 2 weeks prior to study treatment and the chemotherapy toxicity produced by the gemcitabine regimen has recovered to grade 1 or baseline. (3) Age 18 or older, gender-neutral, and physical status ECOG score of 0-2, referenced to the Eastern Cooperative Oncology Group (Zubrod-ECOG-WHO, ZPS) scale. (4) At least one measurable lesion (spiral CT scan =10 mm, meeting RECIST 1.1 criteria). (5) Laboratory data: blood count: total white blood cells = 3.5 × 109/L; neutrophils = 1.5 × 109/L; platelets = 80 × 109/L; hemoglobin = 90 g/L; liver and kidney function: total bilirubin = 1.5 × ULN; AST (SGOT), ALT (SGPT) = 2.5 × ULN, and 50 ml/min (Cockcroft-Gault formula). (6) Good compliance, informed consent must be signed before enrollment. (7) Subjects agree not to participate in other intervention studies during the treatment period.
Exclusion criteria
Exclusion criteria: (1) Patients who have been judged by the investigator or the physician in charge to be unable to use tegeo chemotherapy. Patients on combination of flucytosine, phenytoin or warfarin. (2) Combination of severe cardiovascular system complications, cerebrovascular system complications, interstitial pneumonia or pulmonary fibrosis, active hepatitis, severe hepatic or renal abnormalities, ascites or pleural effusions requiring treatment, brain metastases, other malignancies in situ. (3) Subjects with known or suspected hypersensitivity to known components of yellow and white granular drugs, allergic individuals. (4) Has developed intestinal obstruction that cannot be treated with oral medication and requires intravenous high-energy nutrition. (5) Any unstable condition or condition that may jeopardize the safety of the patient and his or her compliance with the study, such as those with severe mental illnesses such as schizophrenia. (6) Women who are pregnant, lactating, or of childbearing age may not be enrolled, and women of childbearing age may participate unless adequate contraception is available. (7) Participation in other therapeutic clinical trials within 30 days prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| CA19-9;ORR;OS;EORTC QLQ-PAN26\CQ-11D; | — |
Countries
China
Contacts
Public ContactZhong Wang
Outcome results
None listed