Combining Bortezomib with PD-1 antibody and chemotherapy for advanced pancreatic cancer
Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for First-line Treatment of Metastatic Pancreatic Cancer：An Exploratory Clinical Trial
PHASE1; PHASE2 · Zhejiang University · NCT06572813
This study is testing a new combination of treatments, including Bortezomib, a PD-1 antibody, and chemotherapy, to see if it can help people with advanced pancreatic cancer.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University (other) |
| Drugs / interventions | chemotherapy, Sindilizumab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06572813 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-center, prospective, open-label study aimed at evaluating the safety and efficacy of a combination treatment involving Bortezomib, the PD-1 monoclonal antibody Sindilizumab, and mFOLFIRINOX chemotherapy in patients with metastatic pancreatic cancer. The trial is divided into two phases: Phase 1 focuses on assessing drug tolerance and determining the appropriate dosage of Bortezomib, while Phase 2 aims to expand on these findings to evaluate the overall tolerability and efficacy of the treatment regimen. Additionally, the study will explore immunogenicity characteristics and potential biomarkers related to the combination therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with pathologically confirmed metastatic pancreatic ductal adenocarcinoma who have not received prior systemic treatment or have progressed after first-line chemotherapy.
Not a fit: Patients with a history of autoimmune diseases, recent chemotherapy, or those with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced metastatic pancreatic cancer.
How similar studies have performed: While the combination of these specific treatments is novel, similar approaches in targeting metastatic pancreatic cancer have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang
- First Affiliated Hospital of Zhejiang University Schlool of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Tingbo Liang — Zhejiang University
- Study coordinator: Tingbo Liang
- Email: liangtingbo@zju.edu.cn
- Phone: +8619941463683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreas Cancer, metastatic pancreatic cancer, bortezomib, PD-1 antibody, chemotherapy