The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer
This study plans to include 40 patients with borderline resectable pancreatic cancer who are evaluated by a multidisciplinary team (MDT). These patients will receive 3 cycles of neoadjuvant therapy before surgery. The immunotherapy combination chemotherapy regimen consists of liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate, and Camrelizumab, with a 14-day dosing cycle. The chemotherapy regimen consists of liposomal Irinotecan, Oxaliplatin, and 5-Fluorouracil/Calcium folinate. Clinical tumor imaging evaluation will be conducted based on the RECIST 1.1 criteria after the completion of neoadjuvant therapy. The MDT will assess whether patients are eligible for surgery based on the imaging results. The criteria for operability include: no evidence of implantation metastasis during laparoscopic exploration, absence of new metastatic lesions, and the tumor's relationship with blood vessels meeting the criteria for R0/R1 resection. Patients eligible for surgery will undergo pancreatic cancer surgery 4-6 weeks later. Postoperative treatment will be determined by the researchers based on the neoadjuvant treatment effectiveness and the patients'actual conditions. Imaging evaluations will follow the standard diagnostic and treatment guidelines for pancreatic cancer. For patients deemed ineligible for surgery, the subsequent treatment plan will be determined by the researchers based on the neoadjuvant treatment effectiveness and the patients' actual conditions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The treatment regimen for this study is as follows: Intravenous infusion of Oxaliplatin at a dose of 85mg/m2 for 2 hours or according to clinical practice at the research center; Intravenous infusion of liposomal Irinotecan at a dose of 60mg/m2 for 90 minutes (±30 min); Intravenous drip of Calcium folinate at a dose of 400mg/m2 for 30 minutes or according to clinical practice at the research center; Intravenous infusion of 5-Fluorouracil at a dose of 2400mg/m2 (infused for 46-48 hours or according to clinical practice at the research center); Camrelizumab at a fixed dose of 200mg, administered via intravenous drip, with each infusion lasting no less than 30 min and no more than 60 min. Administered on day 1 of every 2-week cycle (d1, q2w). Each treatment cycle is 14 days, and all drugs are administered on day 1.
The treatment regimen for this study is as follows: Intravenous infusion of Oxaliplatin at a dose of 85mg/m2 for 2 hours or according to clinical practice at the research center; Intravenous infusion of liposomal Irinotecan at a dose of 60mg/m2 for 90 minutes (±30 min); Intravenous drip of Calcium folinate at a dose of 400mg/m2 for 30 minutes or according to clinical practice at the research center; Intravenous infusion of 5-Fluorouracil at a dose of 2400mg/m2 (infused for 46-48 hours or according to clinical practice at the research center); Each treatment cycle is 14 days, and all drugs are administered on day 1.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijin, China
RECRUITINGR0 resection rate
Defined as the proportion of subjects with R0 resection assessed postoperatively
Time frame: 1 years
Event free survival (EFS)
The time from randomization to the occurrence of any of the following events, whichever comes first: Radiographic tumor progression evaluated according to RECIST 1.1 criteria. Tumor recurrence assessed by imaging, including local recurrence or distant metastasis. Death due to any cause.
Time frame: 1.5 years
Overall survival (OS)
The time from the initiation of the first dose of medication in a patient to death from any cause.
Time frame: 2 years
Objective Response Rate(ORR)
The proportion of patients with a confirmed complete response or partial response using RECIST 1.1
Time frame: 2year
Disease Control Rate(DCR)
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)
Time frame: 2 years
Safety and tolerability by incidence, severity and outcome of adverse events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Time frame: 2 years
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