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

• ClinicalTrials.gov Identifier: NCT03977272
• Recruitment Status: Completed
• First Posted: June 6, 2019
• Last Update Posted: January 27, 2023
• Sponsor: Zhejiang University
• Information provided by (Responsible Party): TingBo Liang, Zhejiang University

Tracking Information

• First Submitted Date: June 5, 2019
• First Posted Date: June 6, 2019
• Last Update Posted Date: January 27, 2023
• Actual Study Start Date: March 27, 2019
• Actual Primary Completion Date: July 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: June 5, 2019): Overall survival [ Time Frame: Through the study peirod, for 3 years ]

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Cancer

Intervention

• Drug: Combination drug
  Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
• Drug: Chemotherapy
  modified-FOLFIRINOX

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 5, 2019): 110
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 1, 2022
• Actual Primary Completion Date: July 1, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03977272
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: TingBo Liang, Zhejiang University
• Original Responsible Party: Same as current
• Current Study Sponsor: Zhejiang University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Zhejiang University
• Verification Date: January 2023