2024-516835-29-00已完成2 期
Fecal Microbiota Transplant (FMT) combined with Atezolizumab plus Bevacizumab in Patients with HepatoCellular Carcinoma who failed to respond to prior Immunotherapy – the FAB-HCC pilot study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The primary endpoint will be analyzed using descriptive statistics. In detail, the incidence and severity of treatment-related adverse events determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be described.
研究概览
简要总结
Safety as measured by incidence and severity of treatment-related adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Adequate hematological and end-organ function, defined as follows: -AST and ALT < 10 x ULN -Serum bilirubin <3.5 mg/dL - Albumin ≥ 28 g/L - Serum creatinine ≤ 1.5 mg/dL - Hemoglobin ≥ 8 mg/dL - Platelet count ≥ 50 G/L - Leukocytes ≥ 2.5 G/L -Patients not receiving therapeutic anticoagulation: INR ≤ 2.3 or thromboplastin time ≥ 40%
- •Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
- •Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom
- •Age ≥ 18 years
- •Histologically or radiologically confirmed HCC
- •Patients with progressive disease (according to mRECIST) during treatment with atezolizumab/bevacizumab (without or with prior complete or partial response as best radiological response according to mRECIST) OR patients with stable disease as best radiological response (according to mRECIST) after the first 12 months of atezolizumab/bevacizumab treatment
- •Negative HIV test
- •Patients with chronic hepatitis B must be under antiviral treatment and hepatitis B DNA must be <500 IU/mL
- •Variceal status must be known and if present, adequate medical or endoscopic treatment is required
- •ECOG Performance Status 0-1
- •Child-Pugh class A-B8
排除标准
- •Known fibrolamellar carcinoma or mixed cholangiocellular carcinoma
- •Pregnant or breastfeeding women
- •Treatment with systemic immunosuppressive medication with the following exceptions: Acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for contrast allergy) -Mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for adrenal insufficiency
- •Significant vascular disease (e.g., peripheral arterial thrombosis) within 6 months prior to study inclusion
- •Major surgery within 4 weeks prior to study inclusion or minor surgery (excluding placement of a vascular access device) within 3 days prior to study inclusion
- •History of gastrointestinal fistula or perforation, or intraabdominal abscess within 6 months prior to study inclusion
- •Serious, non-healing wound or active ulcer
- •Massive tumor progression (>100% increase in target lesions or progression associated with significant clinical deterioration)
- •Uncontrolled ascites
- •Overt hepatic encephalopathy or concomitant treatment with rifaximin
- •Prior allogeneic stem cell or solid organ transplantation
- •Active or history of severe autoimmune disease
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- •Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to study inclusion or unstable angina
- •Severe infection within 4 weeks prior to study inclusion
结局指标
主要结局
The primary endpoint will be analyzed using descriptive statistics. In detail, the incidence and severity of treatment-related adverse events determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be described.
The primary endpoint will be analyzed using descriptive statistics. In detail, the incidence and severity of treatment-related adverse events determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be described.
次要结局
- Efficacy will be evaluated by the number (percentage) of study participants achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) as best radiological response evaluated according to mRECIST and RECIST v1.1 criteria. Objective response is defined as either complete or partial response, while disease control rate comprises complete/partial response as well as stable disease. Kaplan-Meier method will be used to calculate progression-free survival
- Distribution of quality of life parameters will be assessed by plotting histograms. Baseline and follow-up values will be demonstrated as mean (+/- standard deviation) or median (IQR), as applicable. Changes of quality of life during the study period as assessed by EQ-5D-5L questionnaire will be evaluated using paired T-test or Wilcoxon signed rank test.
研究者
Division of Gastroenterology and Hepatology
Scientific
Medical University Of Vienna
研究点 (1)
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