KCT0004867尚未招募未知
Phase 2 study of first-line regorafenib-nivolumab combination for patients with unresectable hepatocellular carcinoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 42
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 o Limit（—）
- 性别
- All
入选标准
- •1.Age 19 or greater years at time of signing Informed Consent Form
- •2.Ability to comply with the study protocol, in the investigator's judgment
- •3.HCC that was histologically/cytologically confirmed or clinically diagnosed by AASLD criteria in cirrhotic patients. Patients without liver cirrhosis require histological confirmation of HCC
- •4.Locally advanced unresectable or metastatic disease that is not amenable to curative surgical and/or locoregional therapies, or that progressed after surgical and/or locoregional therapies
- •5.No prior systemic therapy for HCC
- •6.At least one measurable (per Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) lesion as confirmed by imaging within 28 days prior to initiation of study treatment
- •7.Patients who received prior local therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization, etc.) are eligible provided that other target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1.
- •8.Pre-treatment tumor tissue sample (if available)
- •-If tumor tissue is available, approximately 10?30 slides containing unstained, freshly cut, serial sections will be required subsequently for translational research.
- •-If tumor tissue is not available (e.g., depleted because of prior diagnostic testing), patients are still eligible.
- •9.ECOG Performance Status score 0 or 1
- •10.Child-Pugh class A
- •11.Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment, unless otherwise specified:
- •-ANC ? 1.0 ? 109/L (1000/?L) without granulocyte colony-stimulating factor support
- •-Platelet count ? 75 ? 109/L (75,000/?L) without transfusion
- •-Hemoglobin ? 90 g/L (9 g/dL): Patients may be transfused to meet this criterion.
- •-AST, ALT, and alkaline phosphatase (ALP) ? 3 ? upper limit of normal (ULN)
- •-Serum bilirubin ? 2 ? ULN
- •-Serum creatinine ? 1.5 ? ULN or creatinine clearance ? 50 mL/min (calculated using the Cockcroft-Gault formula)
- •-Serum albumin ? 28 g/L (2.8 g/dL)
- •-For patients not receiving therapeutic anticoagulation: INR or aPTT ? 2? ULN
- •-Urine dipstick for proteinuria ? 2?
- •-Patients discovered to have ? 2? proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ? 1 g of protein in 24 hours.
- •12.Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade ? 1 prior to study entry, with the exception of alopecia
- •13.Negative HIV result at screening test or prior tested conducted within 3 years
- •14.Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test
- •-Patients with active hepatitis B virus (HBV) must meet the followings: HBV DNA ? 500 IU/mL obtained within 14 days prior to initiation of study treatment, anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study
- •15.Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons)#1 must agree to use contraception#2 from the time of informed consent until 5 months or more after the la
排除标准
- •1.Patients who are diagnosed with fibrolamellar HCC, sarcomatoid HCC, or combined type of cholangiocarcinoma and HCC
- •2.Patients with a history of malignancy other than HCC within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate ? 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, and Stage I uterine cancer
- •3.Patients with a history of leptomeningeal seeding
- •4.Patients with symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- •-Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:
- •(1)The patients must have at least one measurable lesion, per RECIST 1.1, other than CNS metastases
- •(2)The patient must not have a history of intracranial hemorrhage or spinal cord hemorrhage
- •(3)The metastatic lesions have to be limited in cerebellum or supratentorial region (e.g., not to the midbrain, pons, medulla, or spinal cord)
- •(4)There must be no evidence of interim progression between the completion of CNS-directed therapy and initiation of the study treatment
- •(5)The patient must not undergo stereotactic radiotherapy within 7 days, whole-brain radiotherapy within 14 days, or neurosurgical resection within 28 days prior to initiation of the study treatment
- •(6)The patient must not have ongoing requirement for corticosteroids for CNS disease
- •-Anticonvulsant therapy at a stable dose is permitted.
- •-Asymptomatic patients with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy or surgery, with no need to repeat the screening brain scan.
- •5.Patients with current of past history of autoimmune disease or immunodeficient disease (including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjo¨gren syndrome, Guillain-Barre´ syndrome, or multiple sclerosis) with the following exceptions:
- •-Patients with autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible.
- •-Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible.
- •-Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
- •(1)Rash must cover ? 10% of body surface area
- •(2)Disease has to be well controlled at baseline and requires only low-potency topical corticosteroids
- •(3)There must be no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
- •6.Patients with current or past history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
- •-Patients with history of radiation pneumonitis in the radiation field (fibrosis) are eligible if the radiation pneumonitis has been confirmed as stable (beyond acute phase
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