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

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ClinicalTrials.gov Identifier: NCT03983057
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
TingBo Liang, Zhejiang University

Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2019)
Progression-free survival [ Time Frame: Through the study peirod, for 2 years ]
The time of treatment until documented tumor progreesion.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2019)
  • Resection rate [ Time Frame: Through the study peirod, for 2 years ]
    The proportion of patients with surgeical treatment after treatment
  • R0 rate [ Time Frame: Through the study peirod, for 2 years ]
    The proportion of patients with completely tumor resection after treatment
  • Objective response rate [ Time Frame: Through the study peirod, for 2 years ]
    The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
  • Disease control rate [ Time Frame: Through the study peirod, for 2 years ]
    The proportion of patients with tumor size reduction or stable
  • Overall survival [ Time Frame: Through the study peirod, for 2 years ]
    The time of treatment until death.
  • EORTC QLQ - PAN26 score [ Time Frame: Through the study peirod, for 2 years ]
    QLQ score assessed by the European Organization for Research and Treatment of Cancer Quality of Life scale for pancreatic cancer
  • Adverse effects [ Time Frame: Through the study peirod, for 2 years ]
    The most common hematologic and non-hemotologic adverse events
  • Carbohydrate antigen 19-9 [ Time Frame: Through the study peirod, for 2 years ]
    Carbohydrate antigen 19-9 level
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer
Official Title  ICMJE Study on Therapeutic Effect of Combination of Anti-PD-1 Antibody and Chemotherapy in Locally Advanced or Borderline Resectable Pancreatic Cancer Patients: A Randomized Clinical Trial
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Drug: Anti-PD-1 monoclonal antibody
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.
Study Arms  ICMJE
  • No Intervention: Chemotherapy group
    Treatment with modified-FOLFIRINOX Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2
  • Experimental: Combination group
    Treatment with modified-FOLFIRINOX and Anti-PD-1 antibody Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2, Anti-PD-1 antibody 3mg/kg
    Intervention: Drug: Anti-PD-1 monoclonal antibody
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2019)
830
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tingbo Liang, MD PhD 8613666676128 liangtingbo@zju.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983057
Other Study ID Numbers  ICMJE CISPD-4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party TingBo Liang, Zhejiang University
Study Sponsor  ICMJE Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zhejiang University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP