A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer
NCT ID: NCT04425876
Last Updated: 2020-12-31
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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UNKNOWN
PHASE1
74 participants
INTERVENTIONAL
2020-12-17
2023-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fluzoparib+mFOLFIRINOX
Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy
Fluzoparib
Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy
Interventions
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Fluzoparib
Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
* Expected survival ≥ 6 months.
* Histologically or cytologically confirmed pancreas adenocarcinoma.
* Resectable or borderline resectable pancreatic cancer.
* Adequate organ performance based on laboratory blood tests.
* Presence of at least of one measurable lesion in agreement to RECIST criteria.
* Ability to understand and the willingness to receive a needle biopsy.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* Patients with metastasis disease.
* Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan, 5-Fluorouracil or other agents used in the study.
* Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks.
* Significant cardiovascular disease such as New York Heart Associate Class III/IV, cardiac failure, myocardial infarction, unstable arrhythmia, or evidence of ischemia on ECG within 6 months prior to enrolment.
* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
* Patients with myelodysplastic syndrome/acute myeloid leukaemia.
* Patients with second primary cancer except curatively treated in-situ cancer or slowly progressing malignancy.
* Known active hepatitis B or C infection.
* History of immunodeficiency (including HIV infection) or organ transplantation.
* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
18 Years
79 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Boyong Shen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Boyong Shen, M.D.
Role: primary
Other Identifiers
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SHR3162-I-116
Identifier Type: -
Identifier Source: org_study_id