Back to resultsCombination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Combination drug
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Anti-PD-1 Antibody
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
Sites / Locations
- the First Affiliated Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Chemotherapy group
Combination group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Overall survival
The period from the first study treatment to any cause of death
Secondary Outcome Measures
Resection rate
The number of cases received surgery / the total number of evaluable cases (%)
Objective response rate
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)
Disease control rate
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
The period from the first treatment to the first evaluation of PD or any cause of death
Adverse effects
Adverse events occurring through the study treatment, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.
Carbohydrate antigen 19-9
The change of CA 199
EORTC QLQ - PAN26 score
The change of the quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03977272
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Anti-PD-1 Antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Combination group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Combination drug
Intervention Description
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
modified-FOLFIRINOX
Primary Outcome Measure Information:
Title
Overall survival
Description
The period from the first study treatment to any cause of death
Time Frame
Through the study peirod, for 3 years
Secondary Outcome Measure Information:
Title
Resection rate
Description
The number of cases received surgery / the total number of evaluable cases (%)
Time Frame
Through the study peirod, for 3 years
Title
Objective response rate
Description
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)
Time Frame
Through the study peirod, for 3 years
Title
Disease control rate
Description
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 (%)
Time Frame
Through the study peirod, for 3 years
Title
Progression-free survival
Description
The period from the first treatment to the first evaluation of PD or any cause of death
Time Frame
Through the study peirod, for 3 years
Title
Adverse effects
Description
Adverse events occurring through the study treatment, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.
Time Frame
Through the study peirod, for 3 years
Title
Carbohydrate antigen 19-9
Description
The change of CA 199
Time Frame
Through the study peirod, for 3 years
Title
EORTC QLQ - PAN26 score
Description
The change of the quality of life
Time Frame
Through the study peirod, for 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
the First Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer
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