EUCTR2017-003553-42-DE进行中（未招募）1 期
A Phase II single-arm, open-label study of transarterial chemoembolization (TACE) in combination with nivolumab performed for intermediate stage hepatocellular carcinoma (HCC) - IMMUTACE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent including participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •2. Age = 18 years at time of study entry
- •3. Multinodular or large, solitary HCC, not eligible for resection or local ablation, Tumor burden below 50% of liver volume
- •4. Histologically confirmed diagnosis of HCC.
- •5. At least one measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI.
- •6. Child-Pugh A, Performance status (PS) = 2 (ECOG scale)
- •7. Subjects with chronic HBV infection must have HBV DNA viral load < 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy
- •8. Life expectancy of at least 12 weeks.
- •9. Adequate blood count, liver-enzymes, and renal function:
- •- Haemoglobin = 8.5 g/dL, absolute neutrophil count = 1,500 /L, platelets =70 x10^3/L;
- •- Total bilirubin = 3x upper normal limit;
- •- AST (SGOT), ALT (SGPT) = 5 x upper normal limit;
- •- International normalized ratio (INR) =1.25;
- •- Albumin = 31 g/dL;
- •- Serum Creatinine = 1.5 x institutional ULN or creatinine clearance (CrCl) = 30 mL/min (if using the Cockcroft-Gault formula)
- •10. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
- •11. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. Diffuse HCC or presence of vascular invasion or extrahepatic spread with the following exceptions
- •- Invasion of a segmental portal or hepatic veins
- •- Limited extrahepatic metastases with one organ system manifestations, e.g. lymphnodal, pulmonary, ossary metastases. For lymphonodal metastases maximum three metastases, max. 2 cm in the longest diameter, and for all other metastases only solitary metastases, max. 2 cm in the longest diameter, are allowed
- •2. Patients on a liver transplantation list or with advanced liver disease as defined below
- •- Encephalopathy
- •- Untreatable ascites
- •3. Any contraindications for hepatic embolization procedures
- •- Known hepatofugal blood flow
- •- Known porto-systemic shunt
- •- Impaired clotting test (platelet count <70 x103/L, INR >1.25)
- •- Renal failure/ insufficiency requiring hemo-or peritoneal dialysis
- •- Known severe atheromatosis
- •- Total thrombosis or total invasion of the main branch of the portal vein
- •4. History of cardiac disease
- •- Congestive heart failure > NYHA class 2
- •- Active coronary artery disease (myocardial infarction =6 months prior to study entry is allowed)
- •- Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 4.03) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
- •- Uncontrolled hypertension
- •- Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment (TACE + nivolumab)
- •5. Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein
- •6. Prior systemic anti-cancer therapy OR endocrine- OR immunotherapy
- •7. Prior treatment with TACE
- •8. RFA and resection administered less then 4 weeks
- •9. Radiotherapy administered less then 4 weeks
- •10. Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery
- •11. Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix
- •12. Immunocompromised patients, e.g. patients who are known HIV
- •13. Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer
- •14. Previous treatment in the present study
- •15. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to
- •- history of interstitial lung disease
- •- HBV and HCV coinfection
- •- known acute or chronic pancreatitis
- •- active tuberculosis
- •- any other active infection requiring systemic therapy
- •- history of allogeneic tissue/solid organ transplant
- •- diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy treatment
- •- active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
- •- Live vaccine within 30 days prior to the first dose of nivolumab treatment or during study treatment
- •- History or clinical evidence of CNS metastases
- •16. Medication that is known to interfere with any of th
研究者
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