Bortezomib Injection: Bortezomib Injection, a kind of chemotherapy drug
Sintilimab: PD-1 antibody
mFOLFIRINOX: Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 — Up to 2 years. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0,including Complete Blood Count, liver function, renal function lab test and other blood test will be evaluated by using CTCAE 5.0 during study.
Phase 2: Objective reponse rate (ORR) — Up to 2 years The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during phase 2
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou
Zhejiang
Recruiting
More First Affiliated Hospital of Zhejiang University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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