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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.