Combining Bortezomib with PD-1 antibody and chemotherapy for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• First Affiliated Hospital of Zhejiang University Schlool of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Tingbo Liang — First Affiliated Hospital of Zhejiang University
• Study coordinator: Tingbo Liang
• Email: liangtingbo@zju.edu.cn
• Phone: +8619941463683

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.