Pancreas Ductal Adenocarcinoma
Conditions
Keywords
Irinotecan Liposome ,AGN ,pancratic ductal adenocarcinoma,II phase
Brief summary
Based on the superior efficacy and safety profile of liposomal irinotecan over irinotecan in pancreatic cancer, as well as preliminary results from earlier studies evaluating nab-paclitaxel and gemcitabine (AG) combined with liposomal irinotecan, this study aims to further evaluate the efficacy and safety of liposomal irinotecan plus AG as neoadjuvant therapy in patients with resectable or borderline resectable pancreatic cancer (RPC/BRPC). The ultimate goal is to identify a more effective treatment regimen to prolong overall survival in this patient population.
Interventions
DRUGSHR-1701
Neoadjuvant therapy: SHR-1701 1800mg every 4-week cycle
DRUGliposomal irinotecan+nab-paclitaxel+gemcitabine
Neoadjuvant therapy: liposomal irinotecan injection (II) 60mg/m²+ nab-paclitaxel 125mg/m²+ gemcitabine 1000mg/m²+ every 4-week cycle,during which radical surgery will be evaluated by the investigator.
Sponsors
The First Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, male or female; 2. Resectable or borderline resectable pancreatic cancer 3. No prior anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug treatment 4. At least one measurable lesion as a target lesion according to RECIST v1.1 criteria 5. ECOG performance status: 0-1 6. Expected survival time ≥3 months 7. Adequate major organ function
Exclusion criteria
1. Patients with pancreatic tumors originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary neoplasm 2. Known central nervous system (CNS) metastases 3. Severe gastrointestinal dysfunction (e.g., GI bleeding, obstruction, Grade \>2 inflammation, or Grade \> 1 diarrhea); 4. Symptomatic ascites requiring paracentesis or drainage, or patients who have received ascites drainage within the past 3 months (except for those with asymptomatic, controllable minimal ascites detected solely on imaging); 5. Current interstitial lung disease (ILD) or pneumonitis; 6. Known peripheral neuropathy (CTCAE Grade ≥3); 7. Coagulation dysfunction, bleeding tendency, or current thrombolytic or full-dose anticoagulant therapy. 8. Uncontrolled clinical cardiovascular symptoms or diseases； 9. Malignancy other than pancreatic cancer within 5 years prior to randomization, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin； 10. Known hypersensitivity to liposomal irinotecan, other liposomal formulations, gemcitabine, nab-paclitaxel, retlirafusp alfa injection, or any component of these products； 11. Known Acquired Immunodeficiency Syndrome (AIDS), positive HIV antibody test, or active syphilis infection； 12. History of neurological or psychiatric disorders, including epilepsy or dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 Resection Rate | approximately 16 to 20 weeks post-enrollment | Percentage of participants who undergo radical surgical resection and achieve an R0 margin status (defined as microscopically negative surgical margins with no tumor cells at the resection edge, \>1 mm margin clearance). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resection Rate | approximately 16 to 20 weeks post-enrollment | Percentage of participants who undergo surgical resection following neoadjuvant therapy. |
| pCR rate | approximately 16 to 20 weeks post-enrollment | Percentage of participants who achieve a pathological complete response (defined as the complete absence of active tumor cells in the resected surgical specimen including primary tumor and regional lymph nodes, i.e., ypT0yN0). |
| EFS | Up to 18 months | Event-Free Survival |
| OS | Up to 36 months | overall survive |
| ORR | From enrollment to the end of neoadjuvant therapy (approximately 16 weeks) | Objective Response Rate |
| DCR | From enrollment to the completion of neoadjuvant therapy (approximately 16 weeks) | Disease Control Rate |
| safety | From baseline up to 30 days post-surgery or post-last dose | Incidence, severity, and causality of adverse events (AEs), serious adverse events (SAEs), and clinical laboratory abnormalities assessed according to NCI-CTCAE v5.0. |
Countries
China
Outcome results
None listed