Status:
COMPLETED
Sequential Use of AG and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Pancreatic Adenocarcinoma Resectable
Neoadjuvant Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Studies have shown th...
Detailed Description
Investigators chose resectable pancreatic adenocarcinoma patients. The planned treatment was given to the participants after randomization. Tumor size, event-free survival, overall survival, drugs rel...
Eligibility Criteria
Inclusion
- Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
- No evidence of distant metastasis (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.
- Initial assessment for definitive resectable tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2018 first edition standard).
- 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.
- If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.
- Leukocyte count (\> 3.5 x 10\^6 /mL), neutrophil count (\> 1.5 x 10\^6 /mL), platelet count (\> 80 x 10\^6 /mL), hemoglobin (\> 9 g/dL).
- Signed informed consent.
Exclusion
- History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
- Tumor is a local recurrent lesion.
- Imaging confirmed severe portal hypertension / cavernous transformation.
- Ascites
- Gastric outlet obstruction
- Respiratory failure requires supplementation of oxygen.
- Immune deficiency syndrome, such as active tuberculosis and HIV infection.
- Hematological precancerous diseases, such as myelodysplastic syndromes.
- Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
- 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).
- Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
- Severe serious wounds, ulcers or fractures.
- Confirmed coagulant disease.
- Clinical evaluation is unacceptable.
Key Trial Info
Start Date :
October 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT03750669
Start Date
October 20 2018
End Date
March 1 2025
Last Update
May 13 2025
Active Locations (1)
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1
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China