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
Zhejiang University
63 participants
Nov 15, 2024
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
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
Bortezomib Injection, a kind of chemotherapy drug
PD-1 antibody
Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06572813