KCT0007270尚未招募未知
The ABC-HCC Trial: A Phase IIIb, randomized, multicenter, open-label trial of Atezolizumab plus Bevacizumab versus transarterial Chemoembolization (TACE) in intermediate-stage HepatoCellular Carcinoma
IKF GmbH0 个研究点目标入组 45 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
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. Signed Informed Consent Form available
- •2. Patients* = 18 years of age at time of signing Informed Consent Form (for Taiwan: = 20 years)
- •3. Confirmed hepatocellular carcinoma diagnosis based on histopathological findings from tumor tissue or typical diagnostic imaging on dynamic CT or MRI according to AASLD criteria.
- •4. Disease not amenable to curative surgery or transplantation or curative ablation BUT disease amenable to TACE
- •5. Extent of disease according to the following parameters:
- •Multifocal HCC beyond Milan criteria (i.e. >3 lesions of any size OR =ß lesions with at least one of them being = ?cm)
- •More than one untreated HCC untreated nodule > 10 mm showing arterial hyperenhancement
- •No massive multinodular pattern preventing adequate TACE
- •No tumor of a diffuse infiltrative HCC type
- •Patent portal vein flow
- •No portal vein invasion/thrombosis (even segmental) on baseline/eligibility imaging
- •No extrahepatic disease
- •6. Patients with recurrence after resection/ablation are eligible if initially having achieved complete response AND recurrence developed within ß years (i.e. =7?0 days) before trial inclusion AND if = ß untreated nodules with > 10 mm with arterial enhancement are present at timepoint of trial inclusion.
- •7. Child-Pugh score class A without ascites requiring more than 100 mg of spironolactone/day (see exclusion criteria) at enrollment.
- •8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 at enrollment.
- •9. Adequate organ and bone marrow function
- •10. Life expectancy of = ? months
- •11. The following laboratory values obtained less than or equal to 7 days prior to randomization.
- •Platelet count = 75,000 per µL (75x109/L)
- •Hemoglobin = 9.0 g per dL [transfusion allowed]
- •Total bilirubin = ß.0 x the upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 x ULN
- •Serum creatinine = 1.5 x ULN or creatinine clearance (CrCL) = 50mL/min (calculated using the Cockcroft-Gault formula)
- •Urine dipstick for proteinuria = 2+ (within 7 days prior to initiation of study treatment) 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
- •INR or aPTT = 1.5 x ULN (therapeutic anticoagulation prohibited – see exclusion criterion #13; prophylactic anticoagulation permitted, e.g. LMW heparin, ASS up to 250mg/qd)
- •Alkaline phosphatase = ß.5 x ULN
- •Absolute neutrophil count (ANC) = 1.500 per µL (1.5x109/L) without granulocyte colony-stimulating factor support
- •Serum albumin = ß.8 g per dL (ß8g/L)
- •12. Pre-treatment tumor tissue sample (if available)
- •If tumor tissue is available, a formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or approximately 10 to 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report.
- •If FFPE specimens described above are not available, any type of specimens (including fine-needle aspiration, cell pellet specimens [e.g., from pleural effusion], and lavage samples) are also acceptable. This specimen should be accompanied by the associated pathology report.
- •If tumor tissue is not available (e.g., patient has never undergone biopsy or tissue depleted because of prior diagnostic testing), patients are still eligible.
- •13. Negative serum pregnancy test done lesser than or equal to 7 days prior to
排除标准
- •1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- •2. Disease still amenable to curative surgery or transplantation or curative ablation.
- •3. Previous treatment with atezolizumab or bevacizumab.
- •4. Previous treatment with a programmed death 1 (PD1), programmed death-ligand (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or any form of cancer immunotherapy for HCC.
- •5. Previous TACE or any other transarterial treatment for HCC
- •Previous RFA / MWA allowed (refer to inclusion criterion #6)
- •Other local therapies are prohibited (e.g. cryoablation, highintensity focused ultrasound, irreversible electroporation)
- •6. Extent of disease too advanced:
- •Evidence of macrovascular invasion (even segmental) on baseline / eligibility imaging
- •Massive multinodular pattern preventing adequate TACE
- •Extrahepatic disease
- •7. Tumor of diffuse infiltrative HCC type (hypovascular infiltrative tumors with ill-defined borders)
- •8. Clinically meaningful ascites, defined as ascites requiring nonpharmacologic intervention (e.g. paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.
- •Patients with ascites requiring pharmacologic intervention (e.g. diuretics) and stable for =ß months on low doses of diuretics (spironolactone 100 mg/d or equivalent) for ascites are eligible. Of note, diuretics for other indications such as congestive heart failure are not considered in this regard.
- •9. Previous radiotherapy for HCC
- •10. Major surgical procedure, open biopsy, or significant traumatic injury =ß8 days prior to randomization or anticipation of need for major surgical
- •rocedure during the course of the study or non-recovery from side effects of any such procedure.
- •11. Significant cardiovascular disease, such as cardiac disease (New York Heart Association Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, as well as unstable arrhythmias (note: beta blockers or digoxin are permitted), unstable angina, new-onset angina (begun within the last 3 months).
- •12. Uncontrolled hypertension defined by a systolic blood pressure (BP) =150 mmHg or diastolic blood pressure (BP) =100 mmHg, with or without antihypertensive medication. Patients with initial blood pressure (BP) elevations are eligible if initiation or adjustment of antihypertensive medication lowers pressure to meet entry criteria.
- •13. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose.
- •14. History of or current pheochromocytoma.
- •15. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism =6 months prior to randomization.
- •16. With regards to eligibility for adequate TACE, patients presenting with either of the following conditions are excluded:
- •Past history of bilioenteric anastomosis or biliary procedure (e.g., endoscopic papillotomy or biliary stenting) or patients with aerobilia
- •Central biliary obstruction (right or left intrahepatic duct, common hepatic duct, common bile duct)
- •Celiac occlusion
- •17. Ongoing infection > grade 2 NCI-CTCAE version 5.0.
- •18. Patients with seizure disorder requiring medication.
- •19. Prior allogeneic bone marrow transplantation or prior solid organ transpl
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