In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.
In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer. To assess the surgical resection conversion rate of chemotherapy in addition to immunotherapy for unresectable locally advanced pancreatic cancer (LAPC). To evaluate the changes in CA19-9 levels, objective response rate (ORR), R0/R1 resection rate, pathologic response (pCR/MPR), event-free survival (EFS), 1 year and 2 years and overall survival (1y-OS, 2y-OS, OS) before and after conversion therapy for unresectable locally advanced pancreatic cancer. To assess perioperative safety (including surgical morbidity and mortality within 60 days). To evaluate the safety and tolerability of immunotherapy in combination with chemotherapy for conversion therapy for unresectable locally advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Adebrelimab ,20mg/Kg per time, Q4W
Oxaliplatin: 60mg/m2, Q2W
Irinotecan Liposome: 50mg/m2, Q2W
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGSurgical Conversion Rate
The surgery is scheduled to take place after a minimum of 4 weeks from the last dose to allow the effects of the drug to wear off. The eligible subjects can undergo surgery within 8 weeks from the last dose.
Time frame: 8 weeks
Pathologic response rate (pCR/MPR)
pCR is defined as the proportion of subjects with complete disappearance of cancer cells from tumor lesions and lymph nodes. MPR is defined as the proportion of cancer cells in tumor lesions and lymph nodes \< 10% of subjects, and the viable cells of carcinoma in situ are not included in the calculation of pCR. All tumor tissue and associated lymph node tissue samples should be grossly examined. Tissue samples should be sectioned at a thickness of 0.5 cm. Pathological evaluation should be performed for more extensive tumors with at least 1.0 cm thick sections.
Time frame: up to approximately 1 years
Objective response rate (ORR)
ORR=(CR+PR)/ITT\*100%, and the binomial distribution was used to calculate its 95%CI.
Time frame: up to approximately 1 years
Event-free survival (EFS)
defined as the time from the start of treatment to the occurrence of any disease progression affecting surgery, postoperative disease progression or recurrence (per RECIST v1.1), or death due to any cause, whichever occurs first.
Time frame: up to approximately 1 years
Overall survival (OS)
defined as the time from the first dose to death from any cause, whichever occurs first. Participants who were still alive at the last follow-up had OS as data censored at the time of the last follow-up. For participants lost to follow-up, OS was counted as data censored as the time to last confirmed survival before loss-to-follow.
Time frame: up to approximately 1 years
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Calcium Folinate: 400mg/m2, Q2W
Fluorouracil: 2400mg/m2, Q2W