Pancreatic cancer
Conditions
Interventions
Experimental group:Adebelimab + irinotecan liposomal injection II + oxaliplatin+5-FU/LV
Sponsors
Jiangsu Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this trial: (1) Sign a written informed consent before implementing any trial-related procedures; (2) Age: no less than 18 years old and no more than 70 years old, gender not limited; (3) Locally advanced pancreatic cancer confirmed by histopathological/cytopathological examination; (4) Patients in the locally advanced stage who have not previously received anti-tumor treatment (such as radiotherapy, chemotherapy, targeted therapy or immunotherapy, etc.); Definition of locally advanced pancreatic cancer: a. The tumor has no distant metastasis; b. Pancreatic head/uncinate process: Tumor contact with superior mesenteric artery >180 °; c. Pancreatic body and tail: Tumor contact with superior mesenteric artery or abdominal trunk artery >180 °; The tumor contacts the abdominal trunk artery and infiltrates the abdominal aorta. d. The tumor invades the jejunum branch of the superior mesenteric artery. Due to tumor invasion, venous occlusion or involvement of a large area of the superior mesenteric vein jejunal branch, it is impossible to safely reconstruct the portal vein - superior mesenteric vein. (5) According to the Therapeutic Evaluation criteria for Solid Tumors (RECIST version 1.1), there is at least one radiologically measurable lesion; (6) ECOG score: 0-1 point; (7) If biliary obstruction has been relieved, the expected survival time should be greater than 3 months. (8) Sufficient organ function. The subjects need to meet the following laboratory indicators: a) Without the use of granulocyte colony-stimulating factor in the past 14 days, the absolute value of neutrophils (ANC) is >=1.5×10^9/L; b) Without blood transfusion in the past 14 days, the platelet count is greater than or equal to 100×10^9/L; c) Hemoglobin >9 g/dL in the past 14 days without blood transfusion or the use of erythropoietin; d) Total bilirubin =60 mL/min; g) Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; h) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled. (9) For female subjects of childbearing age, a urine or serum pregnancy test should be conducted within 3 days prior to the first administration of the study drug (Day 1 of cycle 1), and the result should be negative. If the result of the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Women of non-childbearing age are defined as those who have been menopausal for at least one year, or have undergone surgical sterilization or hysterectomy. (10) If there is a risk of conception, all subjects (regardless of gender) must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug).
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be allowed to enter the study: (1) Patients with portal hypertension or cavernous degeneration of portal vein; Patients with gastrointestinal bleeding caused by tumors that have involved the gastrointestinal tract; Patients with tumor involvement of digestive tract causing intra-abdominal fistula or abscess; The tumor surrounds the celiac trunk or superior mesenteric artery (SMA) and causes significant involvement of the vascular wall (worm-like changes); Presence of distant metastatic lesions; (2) There is a third space effusion that cannot be controlled by drainage or other methods (such as medium-massive pleural effusion, medium-massive pericardial effusion, ascites); A small amount of pleural effusion or ascites that has no clinical symptoms and does not require clinical intervention should be strictly controlled before enrollment; (3) Those with poor compliance and inability to cooperate and describe treatment responses; (4) Other malignant diseases other than pancreatic cancer diagnosed within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ); (5) Currently participating in interventional clinical study treatment, or received other study drugs or treatment with study devices within 4 weeks prior to the first dose; (6) Have previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs directed at another stimulation or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137); (7) Have received systemic systemic treatment with ready-for-use traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications (including thymosin, interferon, interleukin, except for local use to control ascites) within 2 weeks before the first dose; (8) Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; (9) Were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiological doses of glucocorticoids (<= 10 mg/d of prednisone or equivalent) are allowed; (10) Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; (11) Those who are known to be allergic to the active ingredients or excipients of the study drug adebelimab, leucovorin, 5-fluorouracil, irinotecan and oxaliplatin; (12) have not sufficiently recovered from any intervention-induced toxicities and/or complications prior to initiation of treatment (toxicities not resolved by previous antineoplastic therapy, defined as not resolved to the level specified in the National Cancer Institute Common Terminology Criteria for Adverse Events ((NCI CTCAE v5.0) Grade 0 or 1, or inclusion/exclusion criteria, except for alopecia/pigmentation. For subjects with irreversible toxicities that are not expected to worsen after study drug administration (e.g. hearing loss), inclusion is determined at the discretion of the investigator); (13) Pe
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Event-free survival;Disease control rate;Duration of relief;Disease progression time; | — |
Primary
| Measure | Time frame |
|---|---|
| Surgical conversion rate; | — |
Countries
China
Contacts
Public ContactMin Tu
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed