Clinical trialPhase 1 / Phase 2Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 15 November 2024
- Expected end
- March 2028
- Enrollment
- 63 participants
- Sites
- 1
- Primary outcomes
- Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0; Phase 2: Objective reponse rate (ORR)
- Sponsor
- Other
- Results posted
- No
- Last update
- 10 January 2025
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Brief summary public domain (ClinicalTrials.gov)
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
Detailed description public domain (ClinicalTrials.gov)
Phase 1 (Evaluation of Drug Tolerance) Primary objective: To evaluate the tolerability of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer, and to determine the dose of bortezomib in the combination regimen; Secondary objectives: To evaluate the immunogenicity characteristics and safety of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Phase 2 (Dose Expansion) Primary objective: To evaluate the tolerability and efficacy of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Secondary Objective: ORR; PFS; OS; and to evaluate the immunogenicity and safety of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; and to explore biomarkers related to combination therapy.