Microwave Ablation Combined With Simultaneous TACE Plus Sintilimab for Unresectable HCC.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma.
详细描述
Hepatocellular carcinoma is the most frequent primary and ranked as the sixth most common neoplasm and the third leading cause of cancer death.
Percutaneous ablation and TACE are the effective locoregional treatments for the patient with HCC. Moreover, some studies suggested that TACE combined with ablation could further improve the survival rate and reduce the post-operation complication.
Although PD-1 inhibitor was approved by FDA for HCC, the latest RCT indicated that no significant difference was found in the ORR and PFS between the groups of PD-1 inhibitor and Sorafenib.
Therefore, this study aims to assess the efficacy and safety of microwave ablation combined with simultaneous TACE plus PD-1 inhibitor for the non-resectable HCC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 80 years old and life expectancy of at least 12 weeks.;
- •Clinically or histologically diagnosed as HCC and the diameter of target tumor lesion ≥ 5 cm;
- •Child-pugh classification A or B (score < 7);
- •BCLC Staging as B or C;
- •Patients voluntarily entered the study and signed informed consent form (ICF).
排除标准
- •History of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy;
- •The surgeon assessed that the tumor lesion was not unsuitable for microwave ablation;
- •Any contraindications for hepatic embolization procedures:
- •Known hepatofugal blood flow;
- •Total thrombosis of main portal vein.
- •The tumor thrombus of main portal vein, IVC or right atrium;
- •Tumor burden ≥ 70% of liver volume; and no measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI;
- •Subjects with chronic HBV infection have HBV DNA viral load > 100 IU/mL at screening, and have not received antiviral therapy prior to initiation of study therapy; In addition, coinfection of HBV and HCV;
- •The alcoholic or pregnant women;
- •Patients with second primary cancer or history of other cancer within 3 years;
- •Diagnosis of active autoimmune disease, immunodeficiency, or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Sintilimab-monotherapy treatment;
- •Blood count, liver function: Haemoglobin < 9.0 g/dL, white cell count < 1.0 x10^9/L; Total bilirubin > 3 mg/dL; Aspartate Aminotransferase (SGOT) or Alanine aminotransferase (SGPT) > 5 x upper normal limit (ULN), Albumin < 2.8g/dL; International normalized ratio (INR) >2.3;
- •Renal function dysfunction: Serum Creatinine >2 mg/dL or creatinine clearance (CrCl) < 30 mL/min (if using the Cockcroft-Gault formula ); and severe heart, lung, brain or other organ disease;
- •Non-compliance with TACE or ablation procedure.
研究组 & 干预措施
Locoregional therapies combined with Anti-PD-1 antibody
Percutaneous microwave ablation combined with simultaneous TACE was performed. Sintilimab will be initiated on day 3-7 after the first locoregional therapies. Sintilimab will be administered every three weeks (200mg fixed dose IV) until disease progression for up to one year.The second locoregional procedure will be repeated according to the enhanced CT images.
干预措施: Sintilimab (Drug)
Locoregional therapies combined with Anti-PD-1 antibody
Percutaneous microwave ablation combined with simultaneous TACE was performed. Sintilimab will be initiated on day 3-7 after the first locoregional therapies. Sintilimab will be administered every three weeks (200mg fixed dose IV) until disease progression for up to one year.The second locoregional procedure will be repeated according to the enhanced CT images.
干预措施: Microwave Ablation (Procedure)
Locoregional therapies combined with Anti-PD-1 antibody
Percutaneous microwave ablation combined with simultaneous TACE was performed. Sintilimab will be initiated on day 3-7 after the first locoregional therapies. Sintilimab will be administered every three weeks (200mg fixed dose IV) until disease progression for up to one year.The second locoregional procedure will be repeated according to the enhanced CT images.
干预措施: TACE (Procedure)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Observation period max 18 months
Progression according to mRECIST for HCC.
次要结局
- Incidence of Treatment Emergent Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability)(max 18 months)
- Objective Response Rate (ORR)(max 18 months)
- Time to Progression (TTP)(max 18 months)
- Overall survival (OS)(max 18 months)