PD-1-based Adjuvant Therapy in High-risk Hepatocellular Carcinoma Patients After Curative Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 573
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal options, but the recurrence rate is as high as 70% five years after the operation, and the prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus and microvascular invasion is even worse, so it is particularly urgent to find effective postoperative adjuvant treatment. The role of PD-1 inhibitors in preventing the postoperative recurrence of HCC requires further study.
详细描述
We conducted a prospective cohort study comparing the efficacy of PD-1-based adjuvant therapy and transarterial chemoembolization in patients with high-risk factors for recurrence undergoing radical surgery. After surgery, patients received the appropriate adjuvant therapy according to the type of high-risk recurrence factor. Patients with high-risk factors for recurrence who received PD-1-based adjuvant therapy were included in the exposure cohort; patients with high-risk factors for recurrence who received 1 TACE adjuvant therapy were included in the control cohort. The primary endpoint of this study was disease-free survival, and the overall survival and adverse events were considered as the second endpoint.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •In patients with HCC who received R0 resection, there was no bile duct invasion, extrahepatic invasion, and distant metastasis of lung, bone, and brain
- •Patients with high-risk factors for tumor recurrence (tumor diameter ≥ 5cm, multiple tumors, tumor rupture, AFP ≥ 400 ng/dl, microvascular invasion, portal vein thrombosis, and poorly differentiated) and received PD-1-based adjuvant therapy or TACE adjuvant therapy after the surgery
- •Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
- •Child-Pugh grade A or B
- •The patient knows, and informed consent was obtained
排除标准
- •Any history of other malignant tumors or recurrent HCC
- •Any preoperative treatment for HCC including local and systemic therapy
- •Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
- •Any persistent serious surgery-related complications
- •Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
- •Inability or refusal to comply with the treatment and monitoring
研究组 & 干预措施
PD-1 based therapy cohort
Patients who received PD-1 inhibitors or PD-1 inhibitors plus Lenvatinib therapy 2-4 weeks after the operation were included in the PD-1-based therapy cohort.
干预措施: PD-1 inhibitors (Drug)
TACE cohort
Patients who received 1 TACE about a month after the operation were included in the control cohort.
干预措施: TACE (Procedure)
结局指标
主要结局
Disease-free survival
时间窗: From date of inclued in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months
The primary outcomes of this study include disease-free survival
次要结局
- Overall Survival(From date of inclued in this research until the date of death from any cause, assessed up to 60 months.)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](12months)
研究者
Chen Xiaoping
Professor
Tongji Hospital