Efficacy and Safety of Sequential TACE-SBRT Combined With Targeted Immunotherapy in Patients With Intermediate to Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) according to mRECIST
研究概览
简要总结
The goal of this clinical trial is to evaluate whether sequential transarterial chemoembolization (TACE) followed by stereotactic body radiotherapy (SBRT) combined with targeted immunotherapy is effective and safe for patients with intermediate to advanced hepatocellular carcinoma (HCC) who are not eligible for curative treatment such as surgery or liver transplantation.
This is a single-center, single-arm, retrospective study. All participants included in the analysis will have received the combined treatment regimen.
The main question the study aims to answer is:
Can sequential TACE-SBRT combined with targeted immunotherapy improve the objective response rate (ORR) in patients with intermediate to advanced HCC?
Interventions
Participants in this study have undergone the following treatments:
TACE: a minimally invasive procedure to block the blood supply to the tumor while delivering chemotherapy directly.
SBRT: a highly precise form of radiation therapy targeting the liver tumor. Targeted immunotherapy: systemic treatment that stimulates the immune system to recognize and attack cancer cells.
Participant Population The study includes adult patients diagnosed with intermediate to advanced HCC who were not candidates for curative resection or transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Unresectable hepatocellular carcinoma (HCC)
- •CNLC stage IIb-IIIb
- •Target lesion(s) not previously treated with local therapy
- •Child-Pugh class A5-B7 liver function
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2
- •At least one measurable lesion based on modified RECIST (mRECIST) criteria
排除标准
- •Diagnosis of any malignant disease other than primary liver cancer within 3 years prior to enrollment
- •Currently participating in another interventional clinical study
- •History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
- •Presence of any severe or uncontrolled systemic disease
- •Any medical history, comorbid condition, treatment, or abnormal laboratory finding that may interfere with study results or hinder full participation, or any other situation that the investigator considers inappropriate for enrollment
- •Investigator's judgment of other potential risks making the patient unsuitable for participation in this study
结局指标
主要结局
Objective Response Rate (ORR) according to mRECIST
时间窗: At baseline and every 3 months after treatment initiation, up to study completion (an average of 6months)
Objective response rate (complete response + partial response) assessed by mRECIST based on imaging evaluation.
次要结局
- Progression-Free Survival (PFS) according to mRECIST(From treatment initiation until disease progression or death, whichever occurs first, up to study completion (an average of 15 months))
- Overall Survival (OS)(From treatment initiation until death from any cause, up to study completion (an average of 26 months))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0(From treatment initiation through study completion, up to 18 months)