Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    830
  • sponsor
    Zhejiang University
Updated on 9 February 2022
platelet count
monoclonal antibodies
obstruction
metastasis
neutrophil count
cancer chemotherapy
adenocarcinoma
biliary obstruction
pdac
folfirinox
pancreatic ductal adenocarcinoma
breast ductal carcinoma

Summary

The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with borderline resectable and locally advanced pancreatic cancer.

Description

Investigators chose borderline resectable and locally advanced pancreatic cancer patients. The planned treatment was given to the participants after randomization. Response rate, recurrence-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with borderline resectable and locally advanced pancreatic cancer.

Details
Condition Pancreatic Cancer
Treatment Anti-PD-1 monoclonal antibody
Clinical Study IdentifierNCT03983057
SponsorZhejiang University
Last Modified on9 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 borderline resectable or locally advanced tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2019 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
History of participation of other clinical trails within 4 weeks
History of immunotherapy within 4 weeks
History of receiving chemotherapy, radiotherapy and molecular target therapy within 2 weeks
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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