Actively Recruiting
Bortezomib Combined with PD-1 MAb and MFOLFIRINOX 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
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment involving Bortezomib, Sintilimab (a PD-1 antibody), and mFOLFIRINOX chemotherapy in patients with advanced metastatic pancreatic cancer. This exploratory clinical trial includes both Phase 1 and Phase 2 stages to assess drug tolerability and treatment response in this patient population. Participants in Phase 1 will undergo a dose-finding process for Bortezomib using a 3 + 3 design, involving 6 to 9 patients to determine the optimal dose. Phase 2 will expand enrollment up to 57 patients and use a Bayesian monitoring method to evaluate the objective response rate (ORR) in real time, deciding whether to continue or stop the trial early based on efficacy data. The treatment regimen combines Bortezomib injection, Sintilimab, and the mFOLFIRINOX chemotherapy drugs oxaliplatin, fluorouracil, irinotecan, and leucovorin calcium. During the study, participants will be closely monitored for treatment-related adverse events for up to 2 years in Phase 1, and their tumor response will be assessed in Phase 2. Additional outcomes include disease control rate, duration of remission, progression-free survival, and overall survival. The trial includes regular imaging and laboratory tests to evaluate disease status and safety. Participation may last up to two years, with ongoing follow-up to evaluate long-term effects and biomarkers related to the combination therapy.
CONDITIONS
Brief Title
Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Recurrent or metastatic disease confirmed by imaging.
- No prior systemic treatment or progression after first-line gemcitabine chemotherapy.
- ECOG performance status of 0 or 1.
- Normal serum creatinine and total bilirubin less than 1.5 times upper limit of normal.
- ALT and AST less than 2 times upper limit of normal.
- Signed informed consent.
You will not qualify if you...
- Participation in other clinical trials within 4 weeks.
- History of autoimmune disease or current glucocorticoid treatment.
- Chemotherapy within 2 weeks.
- Radiotherapy or molecular targeted therapy within 2 weeks.
- Active tuberculosis.
- Prior malignancy except certain skin and thyroid cancers.
- Major cardiovascular disease within 6 months.
- Hematological precancerous diseases.
- Clinical or imaging evidence of interstitial lung disease.
- Central nervous system disease unless adequately treated.
- Preexisting neuropathy greater than grade 1.
- Immune deficiency conditions including HIV infection.
- Use of major immunosuppressive therapy.
- Severe wounds, ulcers, or fractures.
- Unacceptable clinical evaluation results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks depending on dose escalation
Participants undergo dose exploration of bortezomib combined with PD-1 antibody and mFOLFIRINOX to evaluate drug tolerance.
Multiple visits during dose escalation
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive the combination regimen of bortezomib, PD-1 antibody, and mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer.
Regular visits for treatment administration and monitoring
Duration - Up to 2 years
Participants are monitored for treatment response, safety, and survival outcomes after treatment ends.
Periodic visits for assessments
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
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