Pancreatic cancer
Conditions
Interventions
Cohort A:Including locally advanced pancreatic cancer, borderline resectable pancreatic cancer with arterial involvement, and borderline resectable pancreatic cancer with both arterial and venous invo
Cohort B:Borderline resectable pancreatic cancer with venous involvement. Patients will receive treatment with gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 (administered on days 1, 8, and 15, w
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, male or female; 2. For patients with borderline resectable/locally advanced pancreatic cancer according to the NCCN Clinical Practice Guidelines for Pancreatic Cancer (2024.V2), the definition of borderline resectable/locally advanced pancreatic cancer according to multidisciplinary and imaging evaluation includes: (1) no distant metastasis; (2) Arteries: 1)Pancreatic head/uncinate process: the tumor was in contact with the common hepatic artery and did not extend to the celiac artery or the bifurcation of the hepatic artery, which could be safely and completely resected and reconstructed; The contact between tumor and superior mesenteric artery was 180°, or contact 180°; 2)Body and tail of pancreas: tumor contact with superior mesenteric artery or celiac artery > 180°; The tumor contacted the celiac artery and infiltrated the abdominal aorta. (3) Vein: it was impossible to reconstruct the portal vein and superior mesenteric vein safely due to tumor invasion, venous occlusion or involvement of a large area of the superior mesenteric vein jejunal branch. 3. Have not received any anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) and investigational drug treatment; 4. At least one measurable lesion must be used as the target lesion (according to RECIST v1.1 criteria); 5. ECOG: 0-1; 6. Expected survival time >=3 months; 7. Good major organ function, that is, meeting the following criteria (without receiving any blood components or cell growth factors within 14 days before enrollment) : (1) neutrophil >=1.5*10^9/L; Platelet count >=80*10^9/L; Hemoglobin>=9g/dl; Serum albumin >=3g/dl; (2) Total bilirubin =60ml/min; (4) INR=50%; 8. Women of childbearing age must have had a negative blood pregnancy test within 3 days before enrollment and be willing to use an appropriate method of contraception during the trial and for 6 months after completion of treatment. For men, surgical sterilization or consent to use an appropriate method of contraception during the stu
Exclusion criteria
Exclusion criteria: 1. Pancreatic cancer originating from non-ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumor; 2. Patients with known central nervous system metastases; 3. Severe gastrointestinal dysfunction (bleeding, obstruction, > grade 2 inflammation, > grade 1 diarrhea); 4. The third space effusion (such as massive pleural effusion) could not reach a stable state (no intervention after drainage tube removal) except ascites within 2 weeks before enrollment; 5. Patients with symptomatic ascites, requiring puncture or drainage, or patients with ascites drainage within the past 3 months (except those with small and controllable ascites on imaging, but without clinical symptoms); 6. Current interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia (e.g., Bronchiolitis obliterans), pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia, or active pneumonia or severely impaired lung function on chest CT during the screening period; Active tuberculosis; 7. Presence of active autoimmune disease or a history of autoimmune disease with potential recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (eligible if controlled only with hormone replacement therapy); Patients with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma that had been completely relieved in childhood without any intervention in adulthood were eligible. 8. Known peripheral neuropathy (CTCAE grade >=3); 9. Known dihydropyrimidine dehydrogenase (low activity) or deficiency; 10. Severe infection (CTCAE > 2) occurred within 4 weeks before enrollment, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. Signs and symptoms of infection requiring treatment with intravenous antibiotics within 2 weeks before enrollment (except for prophylactic antibiotics); 11. Received any of the following: (1) Concomitant medication containing strong inhibitor/strong inducer of CYP3A4 or CYP2C8 or strong inhibitor of UGT1A1 within 2 weeks before enrollment; (2) use of immunosuppressive agents or systemic corticosteroids to achieve immunosuppression within 2 weeks before enrollment (dose >10mg/ day of prednisone or other efficacy hormones); (3) patients received radiotherapy within 2 weeks before enrollment; (4) major surgery (such as thoracotomy, laparotomy, etc.) within 4 weeks before enrollment; (5) receiving any other investigational drug within 4 weeks before enrollment, unless it was an observational (noninterventional) clinical study or an interventional clinical study follow-up. 12. Abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (=100mg/ day), low-molecular-weight heparin (enoxaparin 40mg/ day and its equivalent dose of other low-molecular-weight heparin) was allowed. 13. Have uncontrolled cardiac symptoms or diseases, such as: (1) heart failure above NYHA class 2; (2) unstable angina; (3) myocardial infarction within 6 months; (4) patients with clinically significant supraventricular or ventricular arrhyth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 18 month-OS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Conversion rate;Overall survival;Event-free survival;Overall response rate;Disease control rate;R0 resection;Safety; | — |
Countries
China
Contacts
Public ContactLiang Liu
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed