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Trial record 81 of 266 for:    Pancreatic Cancer AND Resectable

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

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Anti-PD-1 monoclonal antibody Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Anti-PD-1 monoclonal antibody
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Through the study peirod, for 2 years ]
    The time of treatment until documented tumor progreesion.


Secondary Outcome Measures :
  1. Resection rate [ Time Frame: Through the study peirod, for 2 years ]
    The proportion of patients with surgeical treatment after treatment

  2. R0 rate [ Time Frame: Through the study peirod, for 2 years ]
    The proportion of patients with completely tumor resection after treatment

  3. 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

  4. Disease control rate [ Time Frame: Through the study peirod, for 2 years ]
    The proportion of patients with tumor size reduction or stable

  5. Overall survival [ Time Frame: Through the study peirod, for 2 years ]
    The time of treatment until death.

  6. 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

  7. Adverse effects [ Time Frame: Through the study peirod, for 2 years ]
    The most common hematologic and non-hemotologic adverse events

  8. Carbohydrate antigen 19-9 [ Time Frame: Through the study peirod, for 2 years ]
    Carbohydrate antigen 19-9 level



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983057


Contacts
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Contact: Tingbo Liang, MD PhD 8613666676128 liangtingbo@zju.edu.cn

Locations
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China, Zhejiang
the First Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Liang TingBo, MD, PHD    086-571-87236688    liangtingbo@zju.edu.cn   
Sponsors and Collaborators
Zhejiang University

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Responsible Party: TingBo Liang, Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT03983057     History of Changes
Other Study ID Numbers: CISPD-4
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TingBo Liang, Zhejiang University:
Pancreatic cancer
PD-1
FOLFIRINOX
combination therapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs