NCT06572813RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 21 Aug 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Pancreatic cancer
- NCT number
- NCT06572813
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 63
- From 15 Nov 2024 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of autoimmune disease or other condition receiving glucocorticoid treatment
- History of receiving chemotherapy within 2 weeks
- 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)
- Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
Other illness
- History of participation of other clinical trails within 4 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.
- Immune deficiency syndrome, such as active tuberculosis and HIV infection.
Other
- Preexisting neuropathy \> 1 (NCI CTCAE).
- Severe serious wounds, ulcers or fractures.
- Clinical evaluation is unacceptable
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Zhejiang University Schlool of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.