Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer
NCT ID: NCT03977272
Last Updated: 2023-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2019-03-27
2022-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Chemotherapy
modified-FOLFIRINOX
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.
Combination drug
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
Interventions
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Combination drug
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
Chemotherapy
modified-FOLFIRINOX
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Zhejiang University
OTHER
Responsible Party
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TingBo Liang
Proffessor
Locations
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the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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Fu Q, Chen Y, Huang D, Guo C, Zhang X, Xiao W, Xue X, Zhang Q, Li X, Gao S, Que R, Shen Y, Wu J, Zhang M, Bai X, Liang T. Sintilimab Plus Modified FOLFIRINOX in Metastatic or Recurrent Pancreatic Cancer: The Randomized Phase II CISPD3 Trial. Ann Surg Oncol. 2023 Aug;30(8):5071-5080. doi: 10.1245/s10434-023-13383-w. Epub 2023 Apr 13.
Other Identifiers
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CISPD3
Identifier Type: -
Identifier Source: org_study_id
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