JPRN-jRCTs031210694暂停1 期
A single-arm phase II study of atezolizumab plus bevacizumab after stereotactic body radiation therapy in patients with unresectable hepatocellular carcinoma with macrovascular invasion - LIBERATION trial
Maeda Shin0 个研究点目标入组 36 人开始时间: 2022年3月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •A. Signed informed consent Form is obtained
- •B. confirmed diagnosis of hepatocellular carcinoma by histopathological or imaging findings
- •C. Unresectable hepatocellular carcinoma not eligible for local puncture therapy (percutaneous ethanol injection, percutaneous radiofrequency ablation, microwave coagulation necrosis) or radiotherapy alone.
- •D. The diagnosis of primary hepatocellular carcinoma with either Vp3/4 or Vv2/3 according to the 6th edition of the Hepatocellular Carcinoma Treatment Guidelines.
- •E. The following criteria of prior systemic therapy for hepatocellular carcinoma are met.
- •(i) Safety part: No prior systemic therapy for HCC or Second-line systemic therapy after sorafenib or lenvatinib without Vp3/4 or Vv2/3 on imaging findings at the start of the first-line systemic therapy.
- •(ii) Phase II part: No prior systemic drug therapy for hepatocellular carcinoma
- •F. At least one measurable (per RECIST v1.1) lesion within 28 days prior to enrollment
- •G. Tumor evaluation by contrast-enhanced CT or MRI is available
- •H. ECOG Performance Status of 0 or 1
- •I. Child-Pugh classification A liver function
- •J. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 7 days prior to enrollment treatment unless otherwise specified:
- •K. Screening test for HBV, HBV-DNA level less than 500IU/mL obtained at the time of enrollment for patients with continuous HBV infection, and anti-HBV treatment based on the latest guidelines of the Japanese Society of Hepatology for at least 14 days prior to study treatment, and during the study treatment period
排除标准
- •A. Tumour invasion / tumour thrombosis in the splenic vein, superior mesenteric vein, or right atrium on imaging studies within 28 days prior to enrolment
- •B. History of hepatic encephalopathy within 180 days prior to enrollment
- •C. History of cerebral meningitis and tumour invasion of the central nervous system
- •D. Active or history of autoimmune disease requiring systemic treatment (steroids or immunosuppressive drugs)
- •E. A history of active primary immunodeficiency
- •F. Active or history of idiopathic pulmonary fibrosis, drug-induced pneumonia, radiation pneumonitis, idiopathic pneumonia or severe emphysema
- •G. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable
- •angina within 180 days prior to enrollment
- •H.Thrombosis or embolism within 180 days prior to enrolment.
- •I. Clinically uncontrolled hypertension
- •J. Clinically uncontrolled pericardial effusion
- •K. Clinically uncontrolled diabetes mellitus
- •L. History of malignant tumour within 2 years prior to enrolment (except basal cell carcinoma/squamous cell carcinoma of the skin after radical treatment, prostate cancer after radical treatment, cancer of the gastrointestinal tract after radical endoscopic resection, intraepithelial carcinoma, etc.)
- •M. With active infectious diseases with systemic treatment, except hepatitis virus infection
- •N. Known active tuberculosis.
- •O. Histroy of Significant surgical procedure (e.g. open chest, laparotomy, thoracotomy, laparoscopy) undergone an open abdominal biopsy or suturing for significant trauma, or scheduled for major surgical procedure (open chest or laparotomy) during the study period
- •P. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or agents targeting other co-stimulatory or co-inhibitory T-cell receptors (e.g. CTLA-4, OX-40, CD137)
- •Q. History of allergy to chimeric or humanized antibodies or fusion proteins
- •R. Active untreated or under treatment gastroesophageal varices on upper endoscopy within 28 days prior to enrollment
- •S. Clinically uncontrolled pleural effusion or ascites of moderate volume or greater
- •T. TumoursTumours in the mediastinum within 30 mm of the aorta or tracheal bifurcation 6 months prior to enrolment
- •U. Previous radiotherapy in the planned target volume for radiotherapy in this study
- •V. Receiving antithrombotic therapy at therapeutic doses.
- •However, prophylactic antithrombotic therapy is acceptable as long as it is in accordance with the respective national guidelines and drug label. Details of '4 Prophylactic antithrombotic therapy' are provided in section 6.5.3.1 'Prescribed concomitant medications and therapies
- •W. Women who cannot consent to contraception for 9 months after the last dose of bevacizumab and 11 months after the last dose of atezolizumab, who are pregnant, of childbearing potential, within 28 days postpartum, or breastfeeding. Men who wish their partner to become pregnant within 6 months of the last dose of bevacizumab and within 8 months of the last dose of atezolizumab
- •X. History of or complications from any disease, treatment or laboratory abnormality that would preclude the patient from participating in the study in the opinion of the treating physician
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