NCT04842565已完成2 期
Phase II Trial of cTACE Plus Sintilimab for Treatment of Unresectable Intermediate-stage HCC With Beyond Up-to-seven Criteria
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free survival time (mPFS) (mRECIST)
研究概览
简要总结
This study will evaluate the efficacy and safety of Sintilimab plus Transcatheter arterial chemoembolization (TACE) in participants with Intermediate-stage unresectable hepatocellular carcinoma with Beyond Up-to-seven Criteria.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥20 and ≤75 years old
- •Clinically diagnosed or pathologically confirmed advanced hepatocellular carcinoma. ( Fibrolamellae and mixed hepatocellular/cholangiocarcinoma subtypes are not included)
- •CNLC stage IIa/IIb or BCLC stage B, not eligible for resection or local ablation, beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor [in cm] and the number of tumors)
- •Newly diagnosed or recurrent more than half a year after radical surgery
- •No prior TACE treatment,
- •Child-Pugh A, ECOG PS: 0-1
- •Patients with chronic HBV infection must have HBV DNA viral load < 500 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.
- •At least one measurable site of disease as defined by modified RECIST (mRECIST) and RECICL criteria with spiral CT scan or MRI.
- •Life expectancy of at least 3 months.
- •Adequate blood count, liver-enzymes, and renal function: Haemoglobin ≥ 8.5 g/dL, absolute neutrophil count ≥ 1,500/L, platelets ≥70 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula )
- •Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.
- •Normal T3 and T
- •(T3 and T4 controlled in the normal range through treatment is also eligible.)
- •Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
排除标准
- •Diffuse HCC or presence of vascular invasion or extrahepatic spread.
- •The patient suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ).
- •Known history of hepatic encephalopathy within 6 months
- •Known history of cardiac disease within 12 months before the first dose of study drug.
- •Clinically significant hemoptysis or tumor bleeding of any reason within 2 weeks before the first dose of study drug.
- •Severe unhealed wounds, ulcers, or fractures
- •Prior systemic anti-cancer therapy.
- •Prior treatment with TACE.
- •Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- •Any active autoimmune disease or a history of autoimmune disease.
- •Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
- •History of allogeneic tissue/solid organ transplant.
- •Urine routine test showed urine protein ≥ ++ and confirmed 24-hour urine protein content> 1.0 g.
- •Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •Female patients who are pregnant, breast-feeding.
研究组 & 干预措施
TACE+Sintilimab
Experimental
干预措施: TACE (Device)
TACE+Sintilimab
Experimental
干预措施: Sintilimab (Drug)
结局指标
主要结局
Progression-free survival time (mPFS) (mRECIST)
时间窗: Up to approximately 24 months
The progression-free survival time (mPFS) is defined as the date from the first TACE to the date of first documented disease progression as assessed by mRECIST or death.
次要结局
- Overall Survival (OS)(Up to approximately 24 months)
- Percentage of Participants With Adverse Events(Up to approximately 24 months)
- Objective response rate (ORR) by RECIST 1.1 and mRECIST(Up to approximately 24 months)
- Progression-free survival time (mPFS) (RECICL)(Up to approximately 24 months)
- Time to Progression (TTP)(Up to approximately 24 months)
研究者
zheng wang
Associate professor
Fudan University
研究点 (1)
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