EUCTR2020-004210-35-AT进行中（未招募）1 期
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
Institut für Klinische Krebsforschung IKF GmbH0 个研究点目标入组 434 人开始时间: 2021年7月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 434
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. Signed Informed Consent Form available
- •2. Patients* = 18 years of age at time of signing Informed Consent Form (for South Korea: = 19 years and 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. Intermediate stage HCC as defined by the following criteria:
- •Disease not amenable to curative surgery, liver transplantation or curative ablation BUT disease amenable to TACE at enrollment as judged
- •by the investigator.
- •No massive multinodular pattern preventing adequate TACE
- •No tumor of a diffuse infiltrative HCC type (hypovascular infiltrative tumors with ill-defined borders)
- •Patent portal vein flow
- •No main portal vein invasion/thrombosis on baseline/eligibility imaging. Patients with minimal invasion, (Vp1 and Vp2) may be eligible if no exclusion criteria are violated.
- •No extrahepatic disease
- •Note: Patients with HCC beyond Milan criteria who enter a downstaging protocol may be recruited into the trial if they do not present any exclusion criteria.
- •5. Patients with recurrence after resection/ablation or after previous TACE (are eligible, if they – according to the investigator – have an indication for (additional) TACE
- •6. Child-Pugh score class A or B7 without ascites requiring more than 100 mg of spironolactone/day (see exclusion criteria) at enrollment.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at enrollment.
- •8. Adequate organ and bone marrow function
- •9. Life expectancy of = 3 months
- •10. The following laboratory values obtained less than or equal to 7 days prior to randomization.
- •Total bilirubin = 3.0 x the upper limit of normal (ULN)Urine dipstick for proteinuria = 2+ (within 7 days prior to randomization) 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
- •The following other laboratory values measured within 7 days prior to randomization are either normal or if abnormal do not represent a medical contraindication for TACE and atezolizumab/bevacizumab as judged by the investigator: Platelet count, hemoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine, INR or aPTT, alkaline phosphatase, neutrophil count (ANC), and serum albumin.
- •11. Negative serum pregnancy test done lesser than or equal to 7 days prior to randomization, for females of childbearing potential only.
- •12. No presence of untreated or incompletely treated varices with bleeding or high-risk for bleeding: Availability of esophagogastroduodenoscopy (not older than 6 months) in which all size of varices (small to large) had been assessed and varices were treated per local standard of care prior to randomization.
- •13. Absence of other severe comorbidities
- •14. Resolution of any acute, clinically significant treatment-related adverse events from prior therapy/procedure to Grade = 1 prior to randomization, with the exception of alopecia.
- •15. For patients with active hepatitis B virus (HBV):
- •HBV DNA = 2000 IU/mL obtained within 28 days prior to randomization, AND
- •Anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to randomization and willingness to continue
- •treatment for the length of the study.
- •16. For patients with active hepatitis C virus (HCV):
- •Patients positive for hepatitis C vi
排除标准
- •1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC (only if proven by biopsy).
- •2. Previous treatment with atezolizumab or bevacizumab.
- •3. 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.
- •4. Clinically meaningful ascites, defined as ascites requiring non- pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control.
- •Patients with ascites requiring pharmacologic intervention (e.g. diuretics) and stable for =2 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.
- •5. Major surgical procedure, open biopsy, or significant traumatic injury =28 days prior to randomization or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure.
- •6. Significant cardiovascular disease [...] within 3 months prior to randomization [...].
- •7. Uncontrolled hypertension defined by a systolic blood pressure (BP) =150 mmHg or diastolic blood pressure (BP) =100 mmHg, with or without antihypertensive medication. Prior history of hypertensive crisis or hypertensive encephalopathy. (For details see study protocol).
- •8. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose (prophylactic anticoagulation permitted, e.g. new oral anticoagulants [apixaban, dabigatran, rivaroxaban], LMW heparin,
- •ASA up to 300mg/qd).
- •9. Arterial or venous thrombotic or embolic events [...] =6 months prior to randomization.
- •10. 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 (for details see study protocol)
- •11. Any ongoing infection > grade 2 NCI-CTCAE version 5.0. (For details see study protocol).
- •12. Patients with seizure disorder requiring medication.
- •13. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- •14. Evidence or history of bleeding diathesis or any hemorrhage or bleeding event >CTCAE grade 3 within 4 weeks prior to randomization.
- •15. Non-healing wound, ulcer, or bone fracture.
- •16. Renal failure requiring hemo- or peritoneal dialysis.
- •17. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation [...].
- •18. Positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) (for exceptions see study protocol).
- •19. Active tuberculosis
- •20. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
- •21. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •22. Persistent proteinuria of CTCAE Grade 3 or higher (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
- •23. Pregnant or nursing women
- •24. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient i
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