A Retrospective Radiomics-Based Subtyping Study to Guide Post-Downstaging Treatment Selection in Patients With Unresectable Hepatocellular Carcinoma Following TACE Plus Lenvatinib and Anti PD-1
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Recurrence free survival
研究概览
简要总结
The goal of this observational study is to learn about the long-term treatment outcomes for patients with initially unresectable hepatocellular carcinoma (HCC) who achieve successful downstaging with the combination therapy of TACE, lenvatinib, and a PD-1 inhibitor. The main questions it aims to answer are:
Can distinct disease subtypes be identified in successfully downstaged patients using radiomics and clinical data?
Do these different subtypes show significant differences in long-term outcomes, such as recurrence-free survival and overall survival, after undergoing either curative-intent surgical resection or continuing maintenance therapy?
Based on the identified subtypes, can the investigators objectively determine which patients are more suitable for surgical resection and which patients may benefit more from continued maintenance therapy after successful downstaging?
The study will include patients who have already undergone the combination therapy as part of their regular medical care, successfully achieved tumor downstaging (making the tumor technically resectable), and subsequently received either surgical resection or continued maintenance treatment. Researchers will retrospectively analyze their existing clinical and imaging data to compare long-term outcomes between these two treatment paths based on their identified disease subtype.
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
- •Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria;
- •Barcelona Clinic Liver Cancer (BCLC) stage B or C, assessed as unresectable by surgical evaluation; Underwent treatment with TACE combined with lenvatinib and a PD-1 inhibitor, after which the tumor was re-evaluated and deemed resectable by surgical assessment;
- •Following the achievement of surgical resectability criteria, patients subsequently underwent either R0 surgical resection or continued treatment with TACE combined with lenvatinib and a PD-1 inhibitor;
- •Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment;
- •Performance status (PS) score of 0 or 1.
排除标准
- •Patients with unclear diagnoses or those with concurrent other malignancies.
- •For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively.
- •For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors.
- •Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy.
- •Patients with severe infections, such as respiratory, biliary tract, or abdominal infections.
- •Patients with severe underlying diseases, particularly immune-related disorders.
研究组 & 干预措施
Maintenance group
This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after successful downstaging achieved through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, continued with the same non-surgical, maintenance treatment regimen instead of undergoing surgical resection.
干预措施: TACE plus Lenvatinib and PD1 inhibiter (Procedure)
Liver Resection group
This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after achieving successful downstaging through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, underwent curative-intent surgical resection (R0 resection) as their subsequent treatment.
干预措施: Liver resection (Procedure)
结局指标
主要结局
Recurrence free survival
时间窗: From date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months
Time interval from date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months
次要结局
- Overall survival(From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months)
研究者
Wenzhe Fan
Professor
First Affiliated Hospital, Sun Yat-Sen University