Sequential Use of AG and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Oct 20, 2024
  • participants needed
    416
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 1 February 2022

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 that sequential chemotherapeutic regimen can effectively delay the drug resistance and improve the effect of chemotherapy. Here investigators intend to assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox as neoadjuvant chemotherapy for resectable pancreatic adenocarcinoma.

Description

Investigators chose resectable pancreatic adenocarcinoma patients. The planned treatment was given to the participants after randomization. Tumor size, recurrence-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox could or couldn't benefit the prognosis of resectable pancreatic adenocarcinoma.

Details
Condition Pancreatic Adenocarcinoma Resectable, Neoadjuvant Chemotherapy
Treatment mFOLFIRINOX, AG regimen
Clinical Study IdentifierNCT03750669
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on1 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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