KCT0007365招募中未知
A randomized, multicenter, open-label, phase II trial of atezolizumab plus bevacizumab alone or combined with external radiation therapy in patients with macrovascular invasion of hepatocellular carcinoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 138
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
- 20(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •Patients must meet the following criteria for study entry:
- •Signed Informed Consent Form
- •Older than 19 years of age, lower than 80 years of age
- •Child-Pugh class A hepatic function
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
- •Patients with HCC [diagnosed according to AASLD guidelines] invading the intrahepatic vascular system
- •No prior systemic therapy for HCC, at least one measurable HCC lesion with = 1cm diameter
- •Adequate hematologic and organ function
- •- Hemoglobin = 9.0 g/dL
- •- Absolute neutrophil count = 1,000 /mm3
- •- Platelet = 100,000/ mm3 without transfusion
- •- Total bilirubin = 2.5 mg/dL
- •*Patients with known Gilbert disease: total bilirubin ? 3 ? ULN
- •- Albumin = 2.8 g/dL
- •- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) = 5 x upper limit of normal (ULN)
- •- Prothrombin time international normalized ratio = 1.8
- •- Serum creatinine < 1.5 mg/dL
- •For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- •Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ? 200/uL, and have an undetectable viral load}
- •Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test
- •For patients with active hepatitis B virus (HBV): HBV DNA < 2000 IU/mL obtained within 28 days prior to initiation of study treatment, or Anti-HBV treatment (per local standard of care; e.g., entecavir, tenofovir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab. Women must refrain from donating eggs during this same period.
- •– A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- •– Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- •– The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
- •– With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of bevacizumab. Men must refrain from donating sperm during this same period.
- •– With pregnant female partners, men must remain abstinent or use a condom during the treatmen
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Treatment history of prior systemic treatment, or radiotherapy primary of metastatic HCC or tumor thrombosis
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •Asymptomatic patients with treated or untreated CNS lesions are eligible, provided that all of the following criteria are met:
- •– Measurable disease, per RECIST v1.1, must be present outside the CNS.
- •– The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
- •– The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
- •– The patient has no ongoing requirement for corticosteroids as therapy for CNS disease.
- •– If the patient is receiving anti-convulsant therapy, the dose is considered stable.
- •Uncontrolled ascites and hepatic encephalopathy
- •Active infectious condition
- •Patients with peptic ulcer, untreated or incompletely treated varices with bleeding or high-risk for bleeding
- •*Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local standard of care prior to enrollment. Patients who have undergone an EGD within 6 months of prior to initiation of study treatment do not need to repeat the procedure.
- •History of liver transplantation
- •Any serious illness (e.g., active infection or inflammatory condition) or uncontrolled severe medical comorbidity
- •A history of treated malignancy (other than HCC) is allowable if the patient’s malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years
- •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- •Pregnant or breastfeeding women
- •Abdominal/pelvic radiotherapy within 28 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment
- •Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 2 for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:
- •Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.
- •Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- •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:
- •–Rash must cover ? 10% of body surface area.
- •–Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
- •–There has been no occurrence of acute exacerbations of the u
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