A Multicentric, Open-Label Study to Evaluate Tislelizumab in Combination With Transarterial Chemoembolization as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- TTP assessed by independent review committee(IRC)
研究概览
简要总结
A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.
详细描述
This is a multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with conventional transarterial chemoembolization(cTACE) as first-line treatment in BCLC stage C HCC patients without extrahepatic spread. The primary endpoint is time to progression (TTP).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old on the day the patients voluntary to participate in the study and signing in ICF.
- •Histological or clinical diagnosis of HCC.
- •BCLC stage C patients ineligible for surgical resection or liver transplantation.
- •No prior systemic therapy for HCC (including immunotherapy).
- •Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST.
- •Child-Pugh A-B
- •Adequate hematological function (absolute neutrophil count ≥ 1.5 X 109/L, platelets count≥50 X109/L, and hemoglobin ≥85 g/L); Adequate hepatic function (both AST and ALT ≤ 3 ULN, serum total bilirubin ≤ 34.2 umol/L or 2mg/dl, serum albumin ≥ 29g/L); Adequate renal function (eGFR > 30 ml/min/1.73 m2)
- •For patients with HBV or HCV infection, HBV DNA less than 500 IU/ml (2500 copies/ml) or HCV RNA detectable.
- •life expectancy of more than 3 months.
- •Patients must be able to understand and willing to sign a written informed consent document.
- •Patients suitable for TACE therapy assessed by investigators.
排除标准
- •Tumor thrombus involving main trunk of portal vein or inferior vena cava.
- •Prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at BCLC stage 0-B) or radiotherapy on liver cancer.
- •Disease history of grade 2 or more hepatic encephalopathy.
- •Extrahepatic metastasis on baseline imaging.
- •HIV infection or syphilis.
- •Prior therapies with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 agents.
- •Tumor diffuse.
研究组 & 干预措施
Tislelizumab in combination with cTACE
Tislelizumab in combination with on-demanded cTACE
干预措施: Tislelizumab in combination with cTACE (Drug)
结局指标
主要结局
TTP assessed by independent review committee(IRC)
时间窗: up to 24 months after enrollment or study close
Defined as the time from the date of first cTACE to the date of first documentation of disease progression per mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).
次要结局
- PFS(An expected average of 8 months)
- ORR(An expected average of 8 months)
- DCR(An expected average of 8 months)
- DOR(An expected average of 8 months)
- OS(An expected average of 24 months)
- Safety(up to 24 months after enrollment or study close)
- TTP assessed by investigators(An expected average of 8 months)
研究者
Gao-jun Teng
Dr.
Zhongda Hospital