Pancreatic cancer
Conditions
Interventions
Intervention group:1. Albumin-bound paclitaxel: 125 mg/m^2, intravenous infusion, day 1, day 8, Q3W (8 cycles)
2. Gemcitabine: 1000 mg/m^2, intravenous infusion, day 1, day 8, Q3W
3. PD-1 Inhibitor: Intravenous (IV) infusion of PD-1 inhibitors: Sintilimab, Tislelizumab, Pembrolizumab, or Camrelizumab: 200 mg Q3W
Toripalimab: 240 mg Q3W
Other approved PD-1 inhibitors at institutionally standardized doses
4. Sodium Propionate Capsules: 1 g orally three times daily after meals.
After 8 cycles of treatment, maintenance therapy consists of a PD-1 inhibitor plus sodium propionate and gemcitabine.
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75; 2. Patients with pathologically confirmed metastatic or locally advanced unresectable pancreatic cancer who have not received prior systematic therapy; 3. No prior chemotherapy, radiotherapy, immunotherapy, or targeted therapy; or disease progression >6 months after last adjuvant chemotherapy (post-surgery); 4. ECOG PS score of 0 or 1; 5. At least one measurable lesion according to RECIST version 1.1; 6. Adequate organ function defined as: (1) Hepatic function: Total bilirubin (TBIL) =60 mL/min (calculated by Cockcroft-Gault formula); Female: Ccr = [(140 - age) × weight (kg) × 0.85] / [72 × serum creatinine (mg/dL)] Male: Ccr = [(140 - age) × weight (kg) × 1.00] / [72 × serum creatinine (mg/dL)] Note: For patients aged =65 years or those with normal serum creatinine but calculated Ccr =9 g/dL; Absolute neutrophil count >=1.5×10^9/L; Platelets >=100×10^9/L. (5) Cardiac function: New York Heart Association (NYHA) class =50%; Mean QTc interval =12 weeks. Patients of childbearing potential or male patients with partners of childbearing potential must agree to use effective contraception during the entire treatment period and for 180 days after the last dose; 8. Signed written informed consent and willingness to comply with protocol-specified visits and procedures.
Exclusion criteria
Exclusion criteria: 1. Prior systemic antitumor therapy; 2. Use of investigational drugs within 4 weeks before the first study treatment; 3. Major surgery within 4 weeks prior to study treatment initiation without full recovery; 4. Active autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus [SLE]); 5. Chronic immunosuppressive therapy (>10 mg/day prednisone equivalent); 6. Active HIV, HBV, or HCV infection; 7. Live vaccination within 4 weeks prior to study treatment or planned vaccination during the study (except COVID-19 vaccines); 8. Arterial/venous thromboembolic events within 6 months before study treatment (e.g., cerebrovascular accident [including transient ischemic attack], deep vein thrombosis, pulmonary embolism); 9. Symptomatic pleural effusion, pericardial effusion, or ascites uncontrolled by drainage or other interventions; 10. Uncontrolled systemic comorbidities (e.g., diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis); 11. Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh B or higher; 12. Tumor invasion of major blood vessels or trachea with high bleeding/perforation risk, or patients with fistulas; 13. Concurrent participation in another interventional clinical trial (observational studies or follow-up phases of interventional trials are permitted); 14. Palliative local therapy for lesions within 2 weeks before the first dose; 15. Systemic herbal medicine or immunomodulatory agents with antitumor indications (e.g., thymosin, interferon, interleukin) within 2 weeks prior to the first dose; 16. Residual toxicities from prior anticancer therapy not resolved to Grade 7 days (unless corrected >=4 weeks before the first dose); 21. Uncontrolled metabolic disorders or nonmalignant systemic diseases that may increase medical risks or compromise survival assessment; 22. History of other primary malignancies, except: (1) Malignancies in complete remission for >=2 years with no planned treatment during the study; (2) Adequately treated non-melanoma skin cancer or lentigo maligna with no recurrence; (3) Carcinoma in situ with no recurrence after curative therapy; (4) Prostate cancer under active surveillance. 23. Pregnancy, lactation, or intention to conceive (applies to patients or their partners); Other acute or chronic diseases, psychiatric conditions, or abnormal laboratory test values that may lead to any of the following outcomes: increase the risks associated with study participation or study drug administration, interfere with the interpretation of study results, and, in the investigator's judgment, render the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival ;Overall Survival;Duration of Response;Patient-Reported Outcome;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactWang Weilin
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed