RecruitingPhase 1Phase 2NCT06572813

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

Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for First-line Treatment of Metastatic Pancreatic Cancer:An Exploratory Clinical Trial


Sponsor

Zhejiang University

Enrollment

63 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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 Criteria15

  • 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 cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
  • Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
  • Hematological precancerous diseases, such as myelodysplastic syndromes.
  • Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings
  • Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)
  • Preexisting neuropathy > 1 (NCI CTCAE).
  • Immune deficiency syndrome, such as active tuberculosis and HIV infection.
  • Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
  • Severe serious wounds, ulcers or fractures.
  • Clinical evaluation is unacceptable

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Interventions

DRUGBortezomib Injection

Bortezomib Injection, a kind of chemotherapy drug

DRUGSintilimab

PD-1 antibody

DRUGmFOLFIRINOX

Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium


Locations(1)

First Affiliated Hospital of Zhejiang University Schlool of Medicine

Hangzhou, Zhejiang, China

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NCT06572813


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