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

  • STATUS
    Recruiting
  • days left to enroll
    61
  • participants needed
    110
  • sponsor
    Zhejiang University
Updated on 23 January 2021
metastasis
gemcitabine
cancer chemotherapy
adenocarcinoma
metastatic pancreatic cancer
pdac
folfirinox
pancreatic ductal adenocarcinoma
breast ductal carcinoma

Summary

The prognosis of pancreatic cancer is extremely poor. NCCN 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 metastatic pancreatic cancer.

Description

Metastatic pancreatic cancer patients will be enrolled in this trial. Investigators will assign patients to the treatment after randomization. The primary endpoint is overall survival. Response rate, progression-free survival, drugs related side effects and other endpoints events will be recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with metastatic pancreatic cancer.

Details
Condition Pancreatic Cancer, Pancreatic Cancer, Islet Ce417ll Cancer, Pancreatic disorder, Pancreatic Disorders, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Pancreatic Disorders, Islet Ce417ll Cancer, Digestive System Neoplasms, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment Chemotherapy, Combination drug, Combination drug
Clinical Study IdentifierNCT03977272
SponsorZhejiang University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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