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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03977272
Recruitment Status : Completed
First Posted : June 6, 2019
Last Update Posted : January 27, 2023
Sponsor:
Information provided by (Responsible Party):
TingBo Liang, Zhejiang University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Combination drug Drug: Chemotherapy Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2019
Actual Primary Completion Date : July 1, 2022
Actual Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Drug: Chemotherapy
modified-FOLFIRINOX
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 200mg.
 Drug: Combination drug
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: Through the study peirod, for 3 years ]
    The period from the first study treatment to any cause of death


Secondary Outcome Measures :
  1. Resection rate [ Time Frame: Through the study peirod, for 3 years ]
    The number of cases received surgery / the total number of evaluable cases (%)

  2. Objective response rate [ Time Frame: Through the study peirod, for 3 years ]
    The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)

  3. Disease control rate [ Time Frame: Through the study peirod, for 3 years ]
    The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%)

  4. Progression-free survival [ Time Frame: Through the study peirod, for 3 years ]
    The period from the first treatment to the first evaluation of PD or any cause of death

  5. Adverse effects [ Time Frame: Through the study peirod, for 3 years ]
    Adverse events occurring through the study treatment, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.

  6. Carbohydrate antigen 19-9 [ Time Frame: Through the study peirod, for 3 years ]
    The change of CA 199

  7. EORTC QLQ - PAN26 score [ Time Frame: Through the study peirod, for 3 years ]
    The change of the quality of life


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 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).

    • 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
Contacts and Locations
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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): NCT03977272


Locations
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China, Zhejiang
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Zhejiang University
More Information
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Responsible Party: TingBo Liang, Proffessor, Zhejiang University
ClinicalTrials.gov Identifier: NCT03977272    
Other Study ID Numbers: CISPD3
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023
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
Anti-PD-1 Antibody
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases