Actively Recruiting
Bortezomib Combined with PD-1 Antibody Sintilimab and mFOLFIRINOX Chemotherapy for First-line Treatment of Metastatic Pancreatic Cancer An Exploratory Clinical Trial
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
Researchers are investigating the safety and effectiveness of combining Bortezomib, Sintilimab (a PD-1 antibody), and mFOLFIRINOX chemotherapy (oxaliplatin, fluorouracil, irinotecan, leucovorin) for treating advanced metastatic pancreatic cancer. This trial includes two phases: Phase 1 focuses on evaluating how well patients tolerate the drug combination and determining the optimal dose of Bortezomib. Phase 2 expands to assess treatment effectiveness, including response rates and progression-free survival, while exploring immune system effects and biomarkers related to the therapy. Participants receive treatment with Bortezomib injections, Sintilimab antibody, and the mFOLFIRINOX chemotherapy regimen. The study monitors patients closely during both phases to assess safety and treatment impact. The combination regimen is given as the first-line approach for metastatic pancreatic cancer, aiming to control disease progression and evaluate tolerability over time. Throughout the study, participants undergo various assessments including imaging scans (CT, MRI, PET/CT), laboratory tests, and clinical evaluations to monitor disease status and side effects. Safety is tracked through adverse event reporting for up to two years, while treatment response is measured by objective response rates. The study also collects data on survival and immune responses, with informed consent required and follow-up visits scheduled to support comprehensive monitoring during the trial.
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
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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
Y
Yiwen Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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