Clinical trial · Interventional
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
NCT06572813CI-TRIAL-00084563CISPD-7recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib Injection | Drug | Bortezomib | ALIAS |
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 (Drug Tolerance Evaluation)
- description
- Using a 3 + 3 trial design, bortezomib dose exploration was performed to determine the stage 2 bortezomib dose. The number of participants at this stage is 6-9.
- interventionNames
- Drug: Bortezomib Injection
- Drug: Sintilimab
- Drug: mFOLFIRINOX
- type
- EXPERIMENTAL
- label
- Phase 2 (Dose extension)
- description
- Phase 2: This phase will adopt competitive enrollment, and the Bayesian prediction probability method will be used to monitor the main efficacy index of the trial ORR in real time to determine the early termination or continue the trial. A maximum number of 57 patients were enrolled in this stage.
- interventionNames
- Drug: Bortezomib Injection
- Drug: Sintilimab
- Drug: mFOLFIRINOX
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.