A pilot study of Nivolumab with stereotactic ablative radiation therapy after induction chemotherapy in cholangiocarcinoma. - N/A

American University of Beirut0 个研究点目标入组 40 人开始时间: 2021年3月21日最近更新: 2024年8月19日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方: American University of Beirut
入组人数: 40

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
主要目的: Treatment
盲法: Open (masking not used)

入排标准

年龄范围: 18 至 90（—）
性别: All

入选标准

•Inclusion criteria:
•1)Signed and dated informed consent form.
•2)Patients aged =18 years.
•3)Pathologically (histologically or cytologically) and radiologically confirmed diagnosis of non-resectable locally advanced or metastatic or recurrent intrahepatic or extrahepatic CCA within 90 days of registration.
•4)Patients who have stable disease or partial response following 4 cycles of cisplatin/gemcitabine.
•5)ECOG performance score <3
•oAn estimated life expectancy of more than 3 months.
•6)Have adequate hematologic and biochemical function by meeting the following:
•oTotal bilirubin acceptable level = 1.5 × the institutional upper limit of normal (ULN) range;
•oAspartate aminotransferase (AST) and alanine aminotransferase (ALT) acceptable levels up to 5 x ULN range;
•oSerum urea and serum creatinine acceptable levels up to 1.5 x ULN range;
•oCalculated glomerular filtration rate = 45 mL/min according to the Chronic Kidney Disease Epidemiology Collaboration equation (or local institutional standard method).
•7)Negative serum or urine pregnancy test at screening for women of childbearing potential who are sexually active.
•8)Highly effective contraception for both males and females of child-bearing potential who are sexually active throughout the study and for at least 5 months and 7 months after the last Nivolumab treatment administration, respectively.
•9)Candidate for percutaneous biopsy as per tumor location evidenced by CT scan and interventional radiologist.

排除标准

•Exclusion Criteria:
•1. Patients who have progression following 4 cycles of cisplatin/
•gemcitabine evidenced by CT scan as per RECIST 1.1.
•2. Active brain metastases or leptomeningeal metastases.
•3. Prior organ transplantation or allogenic stem-cell transplantation.
•4. Known prior severe hypersensitivity to IMP or any component in its
•formulations, including known severe hypersensitivity reactions to
•monoclonal antibodies (NCI-CTCAE v4.03 Grade = 3).
•5. Active infection requiring systemic therapy within 28 days before the first
•dose of study treatment (e.g., urinary tract infection).
•6. Known history of testing positive for the human immunodeficiency virus
•or known acquired immunodeficiency syndrome.
•7. Evidence of liver cirrhosis.
•8. Current use of immunosuppressive medication, except for the following:
•Intranasal, inhaled, topical steroids, or local steroid injection (e.g.,
•intra-articular injection);
•Systemic corticosteroids at physiologic doses = 10 mg/day of
•prednisone or equivalent;
•Steroids as premedication for hypersensitivity reactions (e.g., CT
•scan premedication).
•9. Active autoimmune diseases that might deteriorate upon receiving an
•immune-stimulatory agent.
•10. Conditions such as vitiligo, psoriasis, diabetes type I, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
•11. Commonly excluded conditions include: Addison’s disease, thyroiditis/
•Hashimoto’s thyroiditis, systemic lupus erythematosus, Sjogren’s
•syndrome, scleroderma, myasthenia gravis, Goodpasture’s syndrome,
•and Grave’s disease
•12. Hepatic insufficiency manifesting as clinical jaundice, hepatic
•encephalopathy, and/or variceal bleed within 60 days prior to study
•13. Transmural myocardial infarction within 6 months of enrollment; provided
•that anti-platelets cannot be stopped to perform percutaneous biopsy.
•14. Congestive heart failure (= New York Heart Association Classification
•Class II) requiring hospitalization within the last 6 months provided that
•anti-platelets cannot be stopped to perform percutaneous biopsy.
•15. Serious cardiac arrhythmia requiring medical treatment provided that
•anti-platelets cannot be stopped to perform percutaneous biopsy.
•16. Recent cerebral vascular accident/stroke within 6 months of enrollment
•provided that anti-platelets cannot be stopped to perform percutaneous
•17. End-stage renal disease requiring dialysis.
•18. Other severe acute or chronic medical conditions including immune
•colitis, inflammatory bowel disease, immune pneumonitis, pulmonary
•fibrosis, or psychiatric conditions including recent (within the past year)
•or active suicidal ideation or behavior.
•19. Vaccination within 4 weeks of the first dose of BMS-936558 and while on
•trial is prohibited except for administration of inactivated vaccines.
•20. Treatment with an investigational agent within 28 days before the first
•dose of study treatment.
•21. Prior treatment with any drug or antibody (anti-PD-1, anti-PD-L1,
•anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody) targeting T cell costimulation or checkpoint pathways.
•22. Patients suspected by the physician that he/she will not be compliant to
另有 6 项未显示

研究者

发起方

American University of Beirut

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