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Trial Title:
Bortezomib Combined With PD-1 mAb and mFOLFIRINOX for Metastatic Pancreatic Cancer
NCT ID:
NCT06572813
Condition:
Pancreas Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Bortezomib
Conditions: Keywords:
metastatic pancreatic cancer
bortezomib
PD-1 antibody
chemotherapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model 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 subjects with advanced metastatic pancreatic cancer; Secondary Objective:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bortezomib Injection
Description:
Bortezomib Injection, a kind of chemotherapy drug
Arm group label:
Phase 1 (Drug Tolerance Evaluation)
Arm group label:
Phase 2 (Dose extension)
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
PD-1 antibody
Arm group label:
Phase 1 (Drug Tolerance Evaluation)
Arm group label:
Phase 2 (Dose extension)
Intervention type:
Drug
Intervention name:
mFOLFIRINOX
Description:
Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium
Arm group label:
Phase 1 (Drug Tolerance Evaluation)
Arm group label:
Phase 2 (Dose extension)
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
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 1, 2024
Completion date:
March 2028
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06572813
