A Randomized Multi-Center Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Lahey Clinic
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- To Compare the Duration of Disease Control in Treated Lesions When Utilizing SBRT Versus TACE as a Bridging Strategy for Patients With HCC Eligible for Liver Transplantation
研究概览
简要总结
This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to liver transplantation in subjects with HCC.
详细描述
For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. For patients undergoing local regional therapy as a bridge to transplantation, trans-arterial chemoembolization (TACE) is the most commonly utilized treatment. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. A newer strategy for the treatment of HCC is stereotactic body radiation therapy (SBRT). This study will compare SBRT to TACE as a bridging strategy for patients with HCC undergoing liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with HCC are eligible for this trial. HCC is defined as having at least one of the following:
- •Biopsy proven HCC or:
- •A discrete hepatic tumor(s) as defined by the Barcelona (29) criteria for cirrhotic subjects, ≥2cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI.
- •Subjects are liver transplant candidates (actively awaiting organ transplant per transplant services in documentation), or, potential liver transplant candidates (at the discretion of the liver team and/or Principal Investigator) advised by liver transplant services as needing local treatment prior to liver transplant evaluation.
- •Subjects must be within UCSF criteria (one solitary tumor smaller than 6.5 cm, or patients having 3 or fewer nodules, with the largest lesion being smaller than 4.5 cm or having a total tumor diameter less than 8.5 cm without vascular invasion) and eligible for potential liver transplant.
- •Subjects must be eligible per standard of care for either TACE or SBRT procedures.
- •Subjects must have a life expectancy of at least 12 weeks.
- •Subjects must be 18 years of age or older. Adult subjects of all ages, both sexes and all races will be included in this study.
- •Subjects must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of record .
- •Subjects must have a Child-Turcotte-Pugh (CTP) score ≤
- •Patients must have adequate organ function within 2 weeks of enrollment.
- •Bone marrow: Platelets ≥30,000/mm3
- •Renal: BUN ≤40 mg/dl; creatinine ≤2.0 mg/dl
- •Hepatic: INR ≤ 1.5 or correctable by Vitamin K, unless anti-coagulated for another medical reason
- •Bilirubin < 3.0 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract, e.g. primary sclerosing cholangitis).
- •Patients uninvolved liver volume will be estimated and must be > 700ml.
- •Patients must have a Zubrod performance status of ≤2.
排除标准
- •Subjects in a "special category" designated by the Public Health Service, Including subjects younger than 18, pregnant women, and prisoners.
- •Refractory ascites that requires paracentesis for management.
- •Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.
- •History of prior radiation to the liver.
- •Evidence of metastatic disease.
- •Presence of a Trans-jugular intra-hepatic porto-systemic shunt (TIPS).
研究组 & 干预措施
Stereotactic Body Radiation Therapy (SBRT)
Radiation Therapy
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Trans-Arterial Chemoembolization (TACE)
Procedure/Surgery - Chemoembolization Drug: Doxorubin
干预措施: Trans-Arterial Chemoembolization (TACE) (Procedure)
Trans-Arterial Chemoembolization (TACE)
Procedure/Surgery - Chemoembolization Drug: Doxorubin
干预措施: Doxorubin (Drug)
结局指标
主要结局
To Compare the Duration of Disease Control in Treated Lesions When Utilizing SBRT Versus TACE as a Bridging Strategy for Patients With HCC Eligible for Liver Transplantation
时间窗: 1 year post treatment
To compare whether or not there was disease present in treated lesions in both the SBRT and TACE arms in patients eligible for liver transplant at 1 year post treatment.
次要结局
- To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0(At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment)
- Number of Further Interventions(2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment)
- Rate of Pathological Response of Treated Lesion(s)(Review of pathology report after liver transplant)
- To Assess Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire(Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment)
- To Assess 90 Day Post-transplant Mortality(Survival status to be captured 90 days post-transplantation (+/- 2 weeks))
- Rate of Radiological Response of Treated Lesion(s)(Baseline, 2 months post-treatment, 5 months post-treatment, every 3 months thereafter until 2 years post treatment)
- To Assess Over Survival(Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment)
- To Assess 90 Day Post-transplant Morbidity(Disease status to be captured 90 days post-transplantation (+/- 2 weeks))