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Recruiting Phase 1, Phase 2 NCT06572813

Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer

Trial Parameters

Condition Pancreas Cancer
Sponsor Zhejiang University
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 63
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-11-15
Completion 2026-09-01
Interventions
Bortezomib InjectionSintilimabmFOLFIRINOX

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC). * Recurrent disease or metastatic disease (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary. * Never receive any systematic treatment or Progression after fisrt line Gemcitabine base chemotherapy * ECOG score 0 or 1. * Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN. * ALT and AST are less than 2 x ULN. * Signed informed consent. Exclusion Criteria: * History of participation of other clinical trails within 4 weeks * History of autoimmune disease or other condition receiving glucocorticoid treatment * History of receiving chemotherapy within 2 weeks * History of radiotherapy and molecular target therapy within 2 weeks * History if active tuberculosis * History of malignance treatment in the past, excluding basal and

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