Patients with metastatic pancreatic cancer who have not received any systemic antitumor treatment during the metastatic stage.
Conditions
Interventions
Control group:Gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15
one treatment cycle every 4 weeks.
Trial group:Liposomal irinotecan hydrochloride (II) 60 mg/m^2 + oxaliplatin 85 mg/m^2 + 5-FU/LV 2400/400 mg/m^2 IV on Days 1 and 15
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years old (including 18 and 75), no gender restrictions; 2. Pancreatic cancer confirmed by histology or cytology (originating from the pancreatic duct epithelium), with clinical records indicating metastatic pancreatic cancer (Stage IV according to AJCC 8th edition pancreatic cancer TNM staging); the first confirmed time of metastasis is within =10 mm or lymph node short-axis >=15 mm according to RECIST v1.1); lesions that have undergone local treatment can be selected as target lesions if there is clear evidence of significant progression after the completion of treatment; 5. Assess ECOG (Eastern Cooperative Oncology Group) performance status score within the 7 days prior to randomization: 0–1 points; the ECOG assessment must be performed back-to-back by two authorized personnel. If the assessment results are inconsistent, the worse score will be considered the true performance status. The following criteria must be met: (1) The patient must not require any assistance with activities of daily living, including eating, dressing, washing, or using the toilet; (2) The patient must not need to lie down for 50% or more of their waking hours; (3) Patients with factors that limit accurate assessment of performance status will not be eligible for the study, including but not limited to patients with preexisting conditions that impair mobility (e.g., spinal or orthopedic disorders, amputees, or pathological obesity with BMI > 40); 6. Expected survival time >=3 months; 7. Major organ functions are normal, meeting the following criteria (no blood transfusions or use of hematopoietic growth factors such as granulocyte colony-stimulating factor [G-CSF] for correction therapy within 14 days prior to randomization): (1) Complete blood count: neutrophils >=1.5×10^9 / L; white blood cells >=3.0×10^9 / L; platelets >=100×10^9 / L; hemoglobin >=90 g/L; (2) Blood biochemistry: serum albumin >=30 g/L; total bilirubin =40 ml/min (calculated by Cockcroft-Gault formula; see protocol appendix) or serum creatinine =2+, 24-hour urine protein quantification must show protein =50%; 8. Women of childb
Exclusion criteria
Exclusion criteria: 1. Pancreatic cancers originating from non-ductal pancreatic epithelium include pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumor; 2. Patients known to have BRCA1/2 or PALB2 mutations; 3. Combined central nervous system metastases; 4. Meets the diagnostic criteria for acute pancreatitis or is accompanied by pancreatitis requiring clinical intervention; 5. Complicated by severe gastrointestinal dysfunction (such as perforation, obstruction, bleeding, diarrhea of CTCAE grade >1, or severe esophageal and gastric varices indicated by endoscopy); 6. Patients with combined biliary obstruction who are at risk of biliary infection (for treatable biliary obstruction, if at least 2 weeks have passed since randomization after treatments such as percutaneous drainage/stent placement and biliary drainage is adequate with no risk of biliary infection, enrollment may be allowed); 7. Within the 2 weeks prior to randomization, presence of third-space fluid (other than ascites) that cannot reach a stable condition (no intervention required after removal of the drainage tube), such as massive pleural effusion; 8. Patients with symptomatic ascites requiring paracentesis or drainage, or who have undergone ascites drainage within the past 3 months (excluding those with only minimal ascites visible on imaging that is controllable and not accompanied by clinical symptoms); 9. Known interstitial lung disease, excluding cases with only radiographic interstitial changes that do not require clinical intervention; 10. Known CTCAE >= grade 3 peripheral neuropathy; 11. Known to have low activity or deficiency of dihydropyrimidine dehydrogenase; 12. Experienced a serious infection (CTCAE > grade 2) within the 4 weeks prior to randomization, such as severe pneumonia, bacteremia, or infection-related complications requiring hospitalization; or had symptoms and signs of infection requiring intravenous antibiotic treatment within 2 weeks prior to randomization (excluding prophylactic use of antibiotics); 13. Includes untreated deep vein thrombosis, coagulation disorders, bleeding risks, or patients undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (<=100 mg/day) and low molecular weight heparin (enoxaparin 40 mg/day or equivalent doses of other low molecular weight heparins) is allowed; 14. Patients with poorly controlled cardiac clinical symptoms or diseases (including but not limited to heart failure of NYHA class II or above; unstable angina; myocardial infarction within the past 6 months; clinically significant supraventricular [e.g., atrial fibrillation] or ventricular arrhythmias [e.g., frequent premature ventricular contractions indicated by 24-hour ECG] that require intervention); 15. Diagnosed with malignant tumors other than pancreatic cancer within the past 5 years (thyroid nodules with TIRADS classification 4b or higher indicated by ultrasound should undergo FNAB to rule out malignancy); excluding adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin; 16. Has received any of the following treatments: (1) Concurrent medication containing strong CYP3A4, CYP2C8 inhibitors/inducers, or strong UGT1A1 inhibitors within 2 weeks prior to randomization; (2) Radiotherapy within 2 weeks prior to randomization; (3) Last anti-tumor treatment (including surgery and anti-tumor traditional Chinese medicine, et
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate;Disease Control Rate;Duration of Response;CA19-9 response rate;Pharmacokinetic (PK) Endpoints: Population PK model parameters, including clearance (CL), volume of distribution (V), etc.;Other endpoints: Laboratory parameters, physical examination, vital signs, electrocardiogram (ECG), echocardiography, adverse events (AEs)/serious adverse events (SAEs) (assessed according to NCI-CTC AE v5.0), etc.; | — |
Countries
China
Contacts
Public ContactWu Wenming
Peking Union Medical College Hospital
Outcome results
None listed