Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06572813

Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer

Led by Zhejiang University · Updated on 2025-01-10

63

Participants Needed

1

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed pancreatic ductal adenocarcinoma (PDAC) by pathology (histology or cytology).
  • Recurrent or metastatic disease shown by abdominal CT, MRI, chest CT or other imaging.
  • No prior systemic treatment or disease progressed after first-line gemcitabine-based chemotherapy.
  • ECOG performance status of 0 or 1.
  • Normal serum creatinine and serum total bilirubin less than 1.5 times the upper limit of normal.
  • ALT and AST liver enzymes less than twice the upper limit of normal.
  • Signed informed consent form.
Not Eligible

You will not qualify if you...

  • Participation in another clinical trial within the past 4 weeks.
  • History of autoimmune disease or current glucocorticoid treatment.
  • Chemotherapy received within the last 2 weeks.
  • Radiotherapy or molecular targeted therapy within the last 2 weeks.
  • Active tuberculosis.
  • Prior cancer treatment history excluding certain skin and thyroid cancers.
  • Major cardiovascular disease in the past 6 months.
  • Hematological precancerous diseases like myelodysplastic syndromes.
  • Signs or history of interstitial lung disease or relevant chest imaging abnormalities.
  • Central nervous system diseases except adequately treated conditions.
  • Preexisting neuropathy grade greater than 1.
  • Immune deficiency conditions such as active tuberculosis or HIV infection.
  • Use of immunosuppressive therapies including for allografts.
  • Severe wounds, ulcers, or fractures.
  • Clinical evaluation deemed unacceptable.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital of Zhejiang University Schlool of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

T

Tingbo Liang

CONTACT

Y

Yiwen Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer | DecenTrialz