This is a prospective, single arm, single center, phase II study of cadonilimab plus mFOLFIRINOX as conversion therapy in patients with locally advanced pancreatic cancer.
Eligible patients with histologically/cytologically confirmed unresectable locally advanced pancreatic cancer (LAPC) will receive cadonilimab (6mg/kg,IVD,D1,Q2W) plus mFOLFIRINOX (oxaliplatin 85mg/m2 , D2 + leucovorin 400mg/m2 , D2 + irinotecan 150mg/m2 , D2 + 5-fluorouracil 2,400mg/m2 46h continuous infusion ) for 4 cycles (8 weeks). After completing every 4 treatment cycles, the subjects will undergo imaging examinations of tumor lesions. If the subjects do not experience disease progression, they will continue to receive treatment until surgical resection, disease progression (RECIST 1.1), or intolerable toxic reactions occur, new anticancer drug treatment begins, withdrawal from the study, death, or loss of follow-up. All subjects who have received treatment are required to undergo efficacy evaluation every 8 weeks (± 7 days) after the start of treatment, until disease progression or study termination. After the 12th cycle of treatment, the maintenance treatment plan is to use capecitabine or S-1 combined with cadonilimab for maintenance treatment. During maintenance treatment, imaging efficacy evaluation is conducted every 12 weeks (± 7 days), and surgical resectability is still evaluated until surgical resection, disease progression (RECIST 1.1) or intolerable toxic reactions occur, new anticancer drug treatment begins, withdrawal from the study, death, or loss of follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Cadonilimab 6 mg/kg,IVD,D1,Q2W +mFOLFIRINOX(Oxaliplatin 85 mg/m2 IV over 4 hours ; Irinotecan 150 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion.) on days 2 of a 14-day cycle.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.
Time frame: Up to 1 year
Progression free survival (PFS)
PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.
Time frame: Up to two years
Overall survival (OS)
The duration from the date of recruitment to the date of death from any cause.
Time frame: Up to two years
Adverse events (safety)
Adverse events (safety ) will be evaluated according to the NCI CTCAE Version 5.0.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.
Time frame: Up to two years
Min Tu, MD
CONTACT
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