pancreatic cancer
Conditions
Interventions
Interventions group:Combination of Irinotecan Liposome II, Gemcitabine, Albumin-Bound Paclitaxel, and Adalimumab
Sponsors
Chinese PLA General Hospital & Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. Patients with locally advanced pancreatic cancer assessed by multidisciplinary and radiographic assessment according to the NCCN Clinical Practice Guidelines for Pancreatic Cancer (2024.V2 version), the definition of locally advanced pancreatic cancer includes: (1) No distant transfer; (2) Arteries: 1) Pancreatic head/uncinate process: tumor tumor contact with the superior mesenteric artery or celiac trunk artery > 180°; 2) Pancreatic tail: the tumor touches the superior mesenteric artery or the celiac trunk artery > 180°; The tumor touches the celiac trunk artery and infiltrates the abdominal aorta; (3) Veins: Due to tumor invasion, vein occlusion or involvement of a large area of superior mesenteric vein jejunal branches, it is impossible to safely reconstruct the portal-superior mesenteric vein; 3. Have not received any anti-tumor treatment (including radiotherapy, ablation, chemotherapy, targeted immunotherapy, etc.), investigational drug treatment; 4. Must have at least one measurable lesion as a target lesion (according to RECIST v1.1 criteria); 5. ECOG:0~1; 6. Expected survival >=3 months; 7. Good major organ function, i.e., meeting the following criteria (not receiving any blood components or cell growth factors within 14 days prior to enrollment): (1) Neutrophils>=1.5×10^9/L; platelets>=80×10^9/L; Hemoglobin>=9g/dl; Serum albumin>=3g/dl; (2) Total bilirubin =60ml/min; (4) INR=50%; 8. Women of childbearing potential must have a blood pregnancy test with a negative result within 3 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and for 6 months after the end of treatment. For men, should be surgically sterile, or agree to use an adequate method of contraception during the study and for 3 months after the end of treatment; 9. Subjects voluntarily join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic blastoma, solid-pseudopapillary tumors; 2. Patients with known central nervous system metastases; 3. Severe gastrointestinal disorders (bleeding, obstruction; Inflammation greater than grade 2; diarrhea greater than grade 1); 4. Presence of third space effusion (such as massive pleural effusion) that cannot reach a stable state (no intervention after drainage removal) except for ascites within 2 weeks prior to enrollment; 5. Patients with clinically symptomatic ascites requiring puncture, drainage, or patients who have undergone ascites drainage in the past 3 months (except for those with only a small amount of ascites on imaging and controllable, but not accompanied by clinical symptoms); 6. Subjects with current interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary fibrosis, organizing pneumonitis (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonitis, or active pneumonitis or severely impaired lung function as shown by chest CT during the screening period; Active tuberculosis; 7. Active autoimmune disease or history of autoimmune disease that may recur [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypohypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects who can only be controlled by hormone replacement therapy can be enrolled)]; Patients with skin diseases such as vitiligo, psoriasis, alopecia, controlled type I diabetes mellitus treated with insulin or asthma in childhood who have completely resolved without any intervention in adulthood can be enrolled; 8. Known peripheral neuropathy (CTCAE>=grade 3); 9. Known dihydropyrimidine dehydrogenase (low activity) or deficiency; 10. Serious infection (CTCAE> grade 2) within 4 weeks before enrollment, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; Presence of symptoms and signs of infection requiring intravenous antibiotic treatment within 2 weeks prior to enrollment (except for prophylactic antibiotic use); 11. Has received any of the following treatments: (1) Concomitant medications containing CYP3A4, CYP2C8 strong inhibitors/strong inducers, or strong UGT1A1 inhibitors within 2 weeks prior to enrollment; (2) Use of immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose> 10mg/day prednisone or other equivalent efficacy hormones) within 2 weeks prior to enrollment; (3) Received radiotherapy within 2 weeks before enrollment; (4) Major surgery (such as thoracotomy, laparotomy, etc.) within 4 weeks before enrollment; (5) Received any other clinical investigational drug treatment within 4 weeks prior to enrollment, unless it is an observational (non-interventional) clinical study or 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 other low molecular weight heparin at its equivalent dose) is allowed; 13. Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA grade 2 or above heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR rate;Overall Survival, OS;Event-free survival,EFS;R0 resection rates;R1 resection rates;objective response rate, ORR;Adverse Event, AE; | — |
Countries
China
Contacts
Public ContactRong Liu
Chinese PLA General Hospital & Medical School
Outcome results
None listed