A Retrospective Study Comparing Interventional Therapy (TACE/HAIC) Combined With PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Versus PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Alone in the First-line Treatment of Intermediate and Advanced Hepatocellular Carcinoma Beyond up to Seven
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- PFS
研究概览
简要总结
This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic Oncology and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or clinically.
- •Patients with Barcelona (BCLC) stage B and C beyond up to seven;
- •Have not received any prior systemic therapy for HCC (including: chemotherapy, molecular targeted therapy, immunotherapy);
- •Receiving only post-marketing PD-1/PD-L1 inhibitors in combination with anti-angiogenic agents (including, but not limited to, drugs containing hepatocellular carcinoma indications);
- •*The interval between the first use of PD-1/PD-L 1 inhibitors and the use of anti-angiogenic drugs is ≤ 1 week
- •TACE was performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;
- •TACE treatment followed by at least 1 cycle of combination therapy, including: cTACE and DEB-TACE;
- •There is at least 1 measurable lesion in the liver according to RECIST v1.1 criteria
排除标准
- •Cholangiocellular carcinoma, mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or hepatic fibrous laminar carcinoma that has been pathologically/histologically confirmed;
- •Patients who do not meet the above definition of combination therapy;
- •Patients had malignant tumors other than HCC within 5 years prior to enrollment (except cured limited tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ)
研究组 & 干预措施
Group LS
Logical therapy combined with systemic therapy
干预措施: PD-1/PD-L1 inhibits and anti-angiogenic agents (Drug)
Group LS
Logical therapy combined with systemic therapy
干预措施: TACE/HAIC (Procedure)
Group S
Systemic therapy alone（PD-1/PD-L1 inhibits and anti-angiogenic agents）
干预措施: PD-1/PD-L1 inhibits and anti-angiogenic agents (Drug)
结局指标
主要结局
PFS
时间窗: Up to 48 months
The time from the beginning of treatment to the time of tumor progression or death from any cause (according to mRECIST and RECIST v1.1)
ORR
时间窗: Up to 48 months
The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST and RECIST v1.1
次要结局
- OS(Up to 48 months)
- Safety(Up to 48 months)
研究者
Lan Zhang
Chief physician
Shanghai Zhongshan Hospital