Survival Analysis of TACE Monotherapy vs. Combination Therapy in BCLC B and C Stage Hepatocellular Carcinoma: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) per mRECIST
研究概览
简要总结
This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC.
详细描述
Standard treatments provide limited benefits for patients with intermediate or advanced hepatocellular carcinoma (HCC). Recently, recommendations on multimodal treatment regimens for patients with locally advanced HCC have attracted much attention. Therefore, this retrospective research was designed to evaluate the clinical outcomes of TACE alone or in combination with immune and targeted therapy in the primary treatment for patients with intermediate to advanced stage HCC.
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
- •Both sexes, aged 18-75 years old; (2) HCC was clinically or pathologically diagnosed according to the American Association for Liver Diseases (ASSLD) criteria; (3) One or more tumor lesions could be measured according to modified response evaluation criteria in solid tumors (mRECIST) on enhanced CT or MRI; (4) For patients with Barcelona Clinic Liver Cancer (BCLC) stage B or stage C hepatocellular carcinoma (HCC) in Barcelona, and who are not suitable for surgical resection, it is recommended to undergo transarterial chemoembolization (TACE) or combination therapy involving TACE as the initial treatment; (5)Child-Pugh grade A or B, no hydrothorax, ascites and hepatic encephalopathy requiring treatment; (6) Eastern Cooperative Oncology Group performance status (ECOG-PS) score 0-1; (7) Have enough liver and kidney function in patients with appropriate laboratory indicators: hemoglobin concentration (HGB) hemoglobin, acuity 9.0 g/dl, neutrophils acuity 1500 cells/mm3, PLT 50 * 109 / L, or serum propagated 28 g/L, or TBIL< 50umol/L, ALT, AST< 5 times the upper limit of normal, Bun, Cr< 1.5 times the upper limit of normal, INR< 1.7 or PT prolongation < 4s
排除标准
- •Other malignant tumors outside HCC, such as liver metastasis of colon cancer; (2) Child-Pugh grade C; (3) Contraindications to TACE, lenvatinib or tislelizumab; (4) Any active autoimmune diseases or autoimmune disease, thyroid function hyperfunction or decline, which is to be bronchodilator treatment of asthma; (5) There are serious complications, including serious heart, lung, kidney, blood coagulation dysfunction; Important cardiovascular diseases such as heart disease of the definition of New York heart association level 3 or higher, instability during the treatment of myocardial infarction, arrhythmia, unstable angina, etc; (6) Past history of patients with idiopathic pulmonary fibrosis , Machine pneumonia (e.g., occlusive bronchiolitis), drug pneumonia, idiopathic pneumonia or chest CT screening to find evidence for an active pneumonia; (7) Patients with previous allogeneic stem cell or solid organ transplantation, including patients after liver transplantation; (8) Clinical data absence or incomplete information.
研究组 & 干预措施
TACE group
Patients included in the study underwent either conventional TACE (cTACE) or drug-eluting beads TACE (DEB-TACE) procedures performed by experienced interventional radiologists, taking into account tumor burden, patient tolerance, and individual preferences.
干预措施: Transarterial chemoembolization (Drug)
Combination group
Systemic treatment commenced within one month after the initial TACE procedure, depending on the proper liver function. Anti-angiogenic agents involved in this study mainly comprised multikinase tyrosine kinase inhibitors. ICIs included therapies targeting programmed cell death protein 1 and its ligands.
干预措施: Transarterial chemoembolization (Drug)
Combination group
Systemic treatment commenced within one month after the initial TACE procedure, depending on the proper liver function. Anti-angiogenic agents involved in this study mainly comprised multikinase tyrosine kinase inhibitors. ICIs included therapies targeting programmed cell death protein 1 and its ligands.
干预措施: Systemic treatment (Other)
结局指标
主要结局
Progression Free Survival (PFS) per mRECIST
时间窗: 12-48 months
The duration from treatment initiation to PD in patients who cannot undergo surgery, or to the date of postoperative relapse in patients who receive surgery, or death for any reason, whichever occurs first (according to mRECIST).
次要结局
- 12 months PFS rate(12 months)
- Disease Control Rate (DCR) per mRECIST(12-48 months)
- Adverse events (AEs)(12-48 months)
- Objective Response Rate (ORR) per mRECIST(12-48 months)
- Overall survival (OS)(24-48 months)
研究者
TingBo Liang
Clinical Professor
Zhejiang University