Clinical trial NCT03977272: Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer
Official title: Comparison of Therapeutic Effect Between Combination of Anti-PD-1 Antibody With mFOLFIRINOX and mFOLFIRINOX Alone in Metastatic Pancreatic Cancer Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Anti-PD-1 Antibody
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Overall survival
timeFrame: Through the study peirod, for 3 years
Secondary outcomes:
measure: Resection rate
timeFrame: Through the study peirod, for 3 years
measure: Objective response rate
timeFrame: Through the study peirod, for 3 years
measure: Disease control rate
timeFrame: Through the study peirod, for 3 years
measure: Progression-free survival
timeFrame: Through the study peirod, for 3 years
measure: Adverse effects
timeFrame: Through the study peirod, for 3 years
measure: Carbohydrate antigen 19-9
timeFrame: Through the study peirod, for 3 years
measure: EORTC QLQ - PAN26 score
timeFrame: Through the study peirod, for 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: