KCT0005554撤回未知
A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma in Korea
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •Diagnosis of intrahepatic cholangiocarcinoma
- •High-quality cross-sectional imaging by computerized tomography (CT) or magnetic resonant imaging (MRI) performed within 6 weeks prior to enrollment and showed a resectable, but high-risk, IHCCA confined to the liver, bile duct, and /or regional lymph nodes. Tumors will be considered high-risk if the high-quality, contrast-enhanced CT and/or MRI +/- positron emission tomography (PET) scan showed:
- •1.T-stage = Ib (Ib – IV)
- •2.Solitary lesion > 5 cm
- •3.Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable
- •4.Presence of major vascular invasion but still technically resectable
- •5.Suspicious or involved regional lymph nodes (N1)
- •6.No distant extrahepatic disease (M0)
- •Adults >18 years of age
- •Able to give informed consent
- •Able to adhere to study visit schedule and other protocol requirements
- •ECOG performance status of 0-1
- •Adequate bone marrow reserves as evidenced by:
- •a)ANC =1,500 cells/µl; and
- •b)Platelet count =100,000 cells/µl; and
- •c)Hemoglobin =9 g/dL
- •Adequate hepatic function as evidenced by:
- •a)Serum total bilirubin =1.5 x ULN; and
- •b)AST and ALT =2.5 x ULN; and
- •c)Albumin =3 g/dl
- •Adequate renal function as evidenced by creatinine =1.5 x ULN.
- •Male, or a non-pregnant and non-lactating female.
- •Women of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception without interruption for 28 days prior to starting gemcitabine/cisplatin/nab- paclitaxel (including dose interruptions) until treatment with gemcitabine/cisplatin/nab-paclitaxel is complete.
- •Male subjects must practice true abstinence or agree to use a condom during sexual
- •contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/cisplatin/nab-paclitaxel and for 6 months following gemcitabine/cisplatin/nab- paclitaxel discontinuation, even if he has undergone a successful vasectomy.
排除标准
- •Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as moderate symptoms; limiting instrumental activities of daily living (ADLs)”.
- •Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness/social situations.
- •Pregnancy (positive pregnancy test) or lactation.
- •Known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
- •Previous (within the past 5 years) or concurrent presence of other cancer, except non-melanoma skin cancer and in situ carcinomas.
- •History of allergy or hypersensitivity to any of the study drugs.
- •Current abuse of alcohol or illicit drugs.
- •Inability or unwillingness to sign the informed consent form.
研究者
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