Efficacy and Safety of Transarterial Chemoembolization (TACE) Combined With Atezolizumab Plus Bevacizumab in Neoadjuvant Therapy for Patients With Hepatocellular Carcinoma: an Open-label, Single-arm, Multicenter, Prospective, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Pathologic Complete Response (pCR) Rate
研究概览
简要总结
This is an open-label, single-arm, multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of TACE combined with Atezolizumab and Bevacizumab as neoadjuvant treatment in Hepatocellular Carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form available
- •Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form
- •Diagnosis of HCC confirmed by histology
- •Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size >5 cm, tumor number >3, vascular invasion (microvascular invasion or macrovascular invasion - Vp1/Vp2 - of the portal vein) and poor tumor differentiation (defined as Grade 3 or 4).
- •Up to three tumors, with largest tumor >5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Four or more tumors, with largest tumor ≤5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Up to three tumors, with largest tumor ≤5 cm with vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) and/or poor tumor differentiation (Grade 3 or 4)
- •Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
- •Child-Pugh A
- •ECOG PS 0～1
- •No prior locoregional or systemic treatment for HCC
- •Negative HIV test at screening
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC
- •Clinically diagnosed hepatic encephalopathy in the last 6 months
- •Autoimmune hepatitis (requiring liver puncture)
- •History of organ transplantation
- •Clinical symptoms of pleural effusion, ascites, pericardial effusion, and any history of kidney disease or nephrotic syndrome
- •Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
- •A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- •Known severe allergic reaction to contrast (e.g., anaphylaxis).
- •Pregnancy or lactating women.
- •Inability to provide informed consent.
研究组 & 干预措施
Atezolizumab + Bevacizumab + TACE
Participants will receive Atezolizumab plus Bevacizumab on Day 1 of a 21-Day cycle, total 5 cycles( Atezolizumab plus Bevacizumab were used in combination for 4 cycles, and Bevacizumab was discontinued in cycle 5. ), after perform 2-3 transarterial chemoembolization procedure on-demand.
干预措施: Atezolizumab (Drug)
Atezolizumab + Bevacizumab + TACE
Participants will receive Atezolizumab plus Bevacizumab on Day 1 of a 21-Day cycle, total 5 cycles( Atezolizumab plus Bevacizumab were used in combination for 4 cycles, and Bevacizumab was discontinued in cycle 5. ), after perform 2-3 transarterial chemoembolization procedure on-demand.
干预措施: Bevacizumab (Drug)
Atezolizumab + Bevacizumab + TACE
Participants will receive Atezolizumab plus Bevacizumab on Day 1 of a 21-Day cycle, total 5 cycles( Atezolizumab plus Bevacizumab were used in combination for 4 cycles, and Bevacizumab was discontinued in cycle 5. ), after perform 2-3 transarterial chemoembolization procedure on-demand.
干预措施: Transarterial chemoembolization (TACE) (Procedure)
结局指标
主要结局
Pathologic Complete Response (pCR) Rate
时间窗: At the time of surgery
pCR rate is defined as the proportion of participants with an absence of residual tumor at the time of surgery, as assessed by central pathological review.
次要结局
- Major Pathologic Response (MPR) Rate(At the time of surgery)
- Relapse-Free Survival (RFS)(Surgery to the first documented recurrence of disease (up to approximately 2 years))
- Event-Free Survival (EFS)(Enrollment up to approximately 2 years)
- Overall Survival (OS)(Enrollment to death from any cause (up to approximately 5 years))
- Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0(From the start of treatment to 30 days after surgery)
研究者
Xinyu Bi
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Cancer Institute and Hospital, Chinese Academy of Medical Sciences