Pancreatic cancer
Conditions
Interventions
experimental group:Traditional Chinese Medicine, radiotherapy, targeted immunotherapy
Sponsors
Southwest University of Medical Sciences Affiliated Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years, gender. (2) Confirmed by histopathology or cytology as locally advanced (unresectable) or metastatic pancreatic ductal adenocarcinoma (PDAC). (3) At least one measurable target lesion according to RECIST 1.1 criteria. (4) ECOG performance status score of 0-2. (5) Expected survival = 3 months. (6) Major organ functions are basically normal and meet the following laboratory requirements (no blood transfusion or growth factor support within the past 14 days prior to screening): - Hematology: Absolute neutrophil count (ANC) = 1.5×10^9/L, Platelet (PLT) = 80×10^9/L, Hemoglobin (Hb) = 90 g/L. - Liver function: Serum total bilirubin (TBIL) = 1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5×ULN (= 5×ULN for liver metastasis). - Renal function: Serum creatinine (Cr) = 1.5×ULN, or Creatinine clearance rate (Ccr) = 50 mL/min. - Coagulation function: International normalized ratio (INR) = 1.5, Activated partial thromboplastin time (APTT) = 1.5×ULN. (7) Signed written informed consent, voluntarily participating in this study and able to comply with treatment and follow-up
Exclusion criteria
Exclusion criteria: (1) Has previously received radiotherapy, chemotherapy, immune checkpoint inhibitors, or anti-angiogenic targeted therapies for pancreatic cancer. (2) Has a history of other active malignant tumors within the past 5 years (except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.). (3) Has active, untreated central nervous system metastases or related symptoms. (4) Has a history of severe cardiovascular diseases (e.g., uncontrolled hypertension, myocardial infarction, unstable angina, stroke). (5) Has active autoimmune diseases, or requires long-term use of immunosuppressants/systemic corticosteroids (equivalent to prednisone >10 mg/day). (6) Has unhealed gastrointestinal ulcers, active bleeding, or high bleeding risk. (7) Known allergy to Yunsui Ningpan Huaji Decoction, Fuzheng Hugai Granules, pembrolizumab, anlotinib, or any of their components. (8) Pregnant or breastfeeding women, or plans to conceive during the study or within 6 months after the last administration. (9) Any medical or social conditions deemed by the investigator to potentially interfere with the assessment of the study, increase patient risks, or hinder compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Disease Control Rate (DCR);Safety and quality of life-related indicators; | — |
Countries
China
Contacts
Public ContactHan Yunwei
Southwest University of Medical Sciences Affiliated Traditional Chinese Medicine Hospital
Outcome results
None listed