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出境医 / 临床实验 / Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer

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

Study Description
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 3

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : March 27, 2021
Estimated Study Completion Date : March 27, 2022
Arms and Interventions
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
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
Layout table for eligibility information
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

Contacts
Layout table for location contacts
Contact: Tingbo Liang +8613666676128 liangtingbo@zju.edu.cn
Contact: Qihan Fu +8615088681610 ayfuqihan@126.com

Locations
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE March 27, 2019
Estimated Primary Completion Date March 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2019) 		Overall survival [ Time Frame: Through the study peirod, for 3 years ]
The period from the first study treatment to any cause of death
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Overall survival [ Time Frame: Through the study peirod, for 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2019)
  • Resection rate [ Time Frame: Through the study peirod, for 3 years ]
    The number of cases received surgery / the total number of evaluable cases (%)
  • 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 (%)
  • 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 (%)
  • 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
  • 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.
  • Carbohydrate antigen 19-9 [ Time Frame: Through the study peirod, for 3 years ]
    The change of CA 199
  • EORTC QLQ - PAN26 score [ Time Frame: Through the study peirod, for 3 years ]
    The change of the quality of life
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Resection rate [ Time Frame: Through the study peirod, for 3 years ]
  • Objective response rate [ Time Frame: Through the study peirod, for 3 years ]
  • Disease control rate [ Time Frame: Through the study peirod, for 3 years ]
  • Progression-free survival [ Time Frame: Through the study peirod, for 3 years ]
  • Adverse effects [ Time Frame: Through the study peirod, for 3 years ]
  • Carbohydrate antigen 19-9 [ Time Frame: Through the study peirod, for 3 years ]
  • EORTC QLQ - PAN26 score [ Time Frame: Through the study peirod, for 3 years ]
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 Metastatic Pancreatic Cancer
Official Title  ICMJE 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
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.
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: Combination drug
    Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
  • Drug: Chemotherapy
    modified-FOLFIRINOX
Study Arms  ICMJE
  • 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
    Intervention: Drug: Chemotherapy
  • 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.
    Intervention: Drug: Combination drug
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 5, 2019) 		110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 27, 2022
Estimated Primary Completion Date March 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tingbo Liang +8613666676128 liangtingbo@zju.edu.cn
Contact: Qihan Fu +8615088681610 ayfuqihan@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977272
Other Study ID Numbers  ICMJE CISPD3
Has Data Monitoring Committee No
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 December 2019

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

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