Study of the Safety, Clinical Efficacy and Prognostic Factors of TACE and/or HAIC Combined With Molecular-targeted Therapy and Immunotherapy for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
The safety, clinical efficacy and prognostic factors of transcatheter arterial chemoembolization (TACE) and/or hepatic artery infusion chemotherapy (HAIC) combined with targeted immunotherapy for primary hepatocellular carcinoma (HCC) require further in-depth study. This research aims to evaluate the safety, clinical efficacy and prognostic factors of TACE and/or HAIC combined with targeted immunotherapy for hepatocellular carcinoma.
We are going to compare and analyze local tumor response, survival outcomes, prognostic factors and adverse events. Tumor response was evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) version. Adverse events were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This study intends to include the targeted and immunotherapy applied, mainly including: lenvatinib, sorafenib, apatinib, bevacizumab, etc.; pembrolizumab, carfilzomib, sintilimab and teprotumumab, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •aged 18-80 years
- •Eastern Cooperative Oncology Group (ECOG) performance status score < 2
- •maximum tumor diameter ≥ 7 cm
- •IVC/RA TT diagnosed by contrast-enhanced CT / MRI before study treatment
- •unresectable HCC (uHCC) confirmed by a specialized multidisciplinary team
- •liver function of Child-Pugh class A or B
排除标准
- •with other malignancies
- •prior anti-tumor therapy
- •history of drug allergy
- •autoimmune diseases
- •digestive hemorrhage of any grade
- •insufficient renal, bone marrow, or coagulation function
研究组 & 干预措施
TACE-HAIC-MTT-PD-1i
干预措施: TACE (transarterial chemoembolization) combined with targeted/immunotherapy (Procedure)