A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 908
- 试验地点
- 218
- 主要终点
- Recurrence-free survival (RFS) for Arm A vs Arm C
研究概览
简要总结
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
详细描述
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 150 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
- Imaging to confirm disease-free status within 28 days prior to randomization
- ECOG 0-1 at enrolment
- Child-Pugh score of 5 or 6
- Adequate organ and marrow function.
排除标准
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
- History of hepatic encephalopathy within 12 months prior to randomization
- Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
- Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
- Active co-infection with HBV and HDV.
- Receipt of prior systemic anticancer therapy for HCC
- Those on a waiting list for liver transplantation
研究组 & 干预措施
Arm C
Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)
干预措施: Placebo (Other)
Arm B
Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
干预措施: Placebo (Other)
Arm A
Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
干预措施: Durvalumab (Drug)
Arm A
Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
干预措施: Bevacizumab (Drug)
Arm B
Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
干预措施: Durvalumab (Drug)
结局指标
主要结局
Recurrence-free survival (RFS) for Arm A vs Arm C
时间窗: Up to 49 months after first patient randomized
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
次要结局
- Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C(Up to 49 months after first patient randomized)
- Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C(At 24 and at 36 months)
- Recurrence-free survival (RFS) Arm B vs Arm C(Up to 49 months after first patient randomized)
- Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C(No timeframe)
- Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C(Up to 49 months after first patient randomized)
研究者
研究点 (218)
标识符
- NCT 编号
- NCT03847428
- 其他研究编号
- D910DC00001, 2023-507689-26-00, 2018-004105-85
日期
- 首次提交
- (7年前)
- 首次发布
- (7年前)
- 主要完成日期
- (4个月前)
- 研究完成日期
- (8个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure