Actively Recruiting
Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer
Led by Zhejiang University · Updated on 2025-01-10
63
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed pancreatic ductal adenocarcinoma (PDAC) by pathology (histology or cytology).
- Recurrent or metastatic disease shown by abdominal CT, MRI, chest CT or other imaging.
- No prior systemic treatment or disease progressed after first-line gemcitabine-based chemotherapy.
- ECOG performance status of 0 or 1.
- Normal serum creatinine and serum total bilirubin less than 1.5 times the upper limit of normal.
- ALT and AST liver enzymes less than twice the upper limit of normal.
- Signed informed consent form.
You will not qualify if you...
- Participation in another clinical trial within the past 4 weeks.
- History of autoimmune disease or current glucocorticoid treatment.
- Chemotherapy received within the last 2 weeks.
- Radiotherapy or molecular targeted therapy within the last 2 weeks.
- Active tuberculosis.
- Prior cancer treatment history excluding certain skin and thyroid cancers.
- Major cardiovascular disease in the past 6 months.
- Hematological precancerous diseases like myelodysplastic syndromes.
- Signs or history of interstitial lung disease or relevant chest imaging abnormalities.
- Central nervous system diseases except adequately treated conditions.
- Preexisting neuropathy grade greater than 1.
- Immune deficiency conditions such as active tuberculosis or HIV infection.
- Use of immunosuppressive therapies including for allografts.
- Severe wounds, ulcers, or fractures.
- Clinical evaluation deemed unacceptable.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Tingbo Liang
CONTACT
Y
Yiwen Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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