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Recruiting NCT06572813

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

Phase I / Phase II Interventional Pancreas Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bortezomib Injection, Sintilimab, mFOLFIRINOX.
Who it may be relevant to
Registry conditions: Pancreas Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for First-line Treatment of Metastatic Pancreatic Cancer：An Exploratory Clinical Trial

Overview

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

Detailed description

Phase 1 (Evaluation of Drug Tolerance) Primary objective: To evaluate the tolerability of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer, and to determine the dose of bortezomib in the combination regimen; Secondary objectives: To evaluate the immunogenicity characteristics and safety of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Phase 2 (Dose Expansion) Primary objective: To evaluate the tolerability and efficacy of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Secondary Objective: ORR; PFS; OS; and to evaluate the immunogenicity and safety of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; and to explore biomarkers related to combination therapy.

Interventions

  • Drug Bortezomib Injection
    Bortezomib Injection, a kind of chemotherapy drug
  • Drug Sintilimab
    PD-1 antibody
  • Drug mFOLFIRINOX
    Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium

Primary outcome measures

  • Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Up to 2 years.]
  • Phase 2: Objective reponse rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (4)
  • Disease control rate (DCR) [Time frame: Up to 2 years]
  • Duration of remission （DoR） [Time frame: Up to 2 years]
  • Progression-free survival （PFS） [Time frame: Up to 2 years]
  • Overall survival (OS) [Time frame: Up to 2 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • First Affiliated Hospital of Zhejiang University Schlool of Medicine — Hangzhou

Identifiers

NCT: NCT06572813 · CISPD-7

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗