This is an single-center, prospective, open-label clinical trial, to explore the safty and efficacy of combination of Bortezomib, Sindilizumab, and mFOLFIRINOX Chemotherapy (oxaliplatin, fluorouracil, irinotecan, leucovorin) in metastatic pancreatic cancer
Phase 1 (Evaluation of Drug Tolerance) Primary objective: To evaluate the tolerability of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer, and to determine the dose of bortezomib in the combination regimen; Secondary objectives: To evaluate the immunogenicity characteristics and safety of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Phase 2 (Dose Expansion) Primary objective: To evaluate the tolerability and efficacy of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Secondary Objective: ORR; PFS; OS; and to evaluate the immunogenicity and safety of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; and to explore biomarkers related to combination therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Bortezomib Injection, a kind of chemotherapy drug
PD-1 antibody
Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China
RECRUITINGPhase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0,including Complete Blood Count, liver function, renal function lab test and other blood test will be evaluated by using CTCAE 5.0 during study.
Time frame: Up to 2 years.
Phase 2: Objective reponse rate (ORR)
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during phase 2
Time frame: Up to 2 years
Disease control rate (DCR)
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during phase 2
Time frame: Up to 2 years
Duration of remission (DoR)
The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause during phase 2
Time frame: Up to 2 years
Progression-free survival (PFS)
The time from enrolled to disease pregression or death from any cause during phase 2
Time frame: Up to 2 years
Overall survival (OS)
The time from enrolled to death from any cause during phase 2
Time frame: Up to 2 years
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