Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Overall Survival Rate Between Time of Consent and Time of Death
研究概览
简要总结
This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are candidates to receive both proton beam and sorafenib
- •Patients with tumor burden that exceeds San Francisco criteria
排除标准
- •Patients who are candidates for surgical resection
- •Patients with tumor burden within Milan and/or San Francisco criteria
- •Patients who have contraindication to receive proton
- •Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
- •Patients treated previously by any locoregional treatment
- •Patients with prior liver transplant
- •Patients with child class C
- •Patients with model for end-stage liver disease (MELD) score of > 25
- •Patients with other comorbid diseases that may impact survival
- •Patients with ongoing alcohol intake
- •Patients with active sepsis
- •Patients with gastrointestinal bleeding within a week
- •Patients unwilling to sign informed consent form
- •Patients with history of noncompliance
研究组 & 干预措施
Proton Beam Radiotherapy plus Sorafenib
A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.
干预措施: Proton Beam Radiotherapy (Radiation)
Proton Beam Radiotherapy plus Sorafenib
A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.
干预措施: Sorafenib (Drug)
Sorafenib
Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Overall Survival Rate Between Time of Consent and Time of Death
时间窗: Change between time of informed consent and primary completion date of study, an average of 4 years per participant
All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months.
次要结局
未报告次要终点