Conventional Transarterial Chemoembolization (cTACE) or Transarterial Chemoembolization (DEB-TACE) +HAIC Combined With Regorafenib ± Anti-PD1 Antibody for Unresected Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Progression free overall survival，PFS
研究概览
简要总结
explore the effectiveness and safety of conventional transarterial chemoembolization (cTACE) or transarterial chemoembolization (DEB-TACE) plus hepatic arterial Infusion chemotherapy (HAIC) combined with regorafenib and anti-PD-1 antibody or not for unresected hepatocellular carcinoma (uHCC)
详细描述
This is a non-randomized, open, single-arm clinical study. Patients receive cTACE/DEB-TACE+HAIC treatment( 6-8 weeks as a cycle) and regorafenib and anti-PD1 antibody or not until the disease progresses, intolerable toxicity occurs, the patient is lost to follow-up or death, or situations other judged by researchers which treatment should be stopped.
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
- •Volunteer to participate and sign the informed consent in writing;
- •Age: 18-75 years old;
- •No gender limit;
- •Unresectable hepatocellular carcinoma with clear pathological diagnosis or clinical diagnosis;
- •Unresectable hepatocellular carcinoma patients who failed first-line treatment (including but not limited to sorafenib, lenvatinib, atezolizumab combined with bevacizumab, etc.);
- •At least one measurable lesion (according to mRECIST criteria) imaging diagnosis time ≤ 21 days from selection;
- •Child-pugh grade A-B7 grade
- •The expected survival period is ≥3 months;
- •General physical condition (ECOG) 0-2;
- •Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dL, white blood cells ≥3.0×10^9/L, neutrophils ≥1.5x 10^9/L, platelets ≥80x 10^9/L; liver and kidney functions are normal; (Within 14 days): TBIL≤1.5 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; creatinine≤1.5 times the upper limit of normal; INR≤1.7 or prolonged PT≤4s.
排除标准
- •Those who are currently receiving other effective treatments;
- •Patients who have received regorafenib in the past;
- •Patients who have participated in other clinical trials within 4 weeks before enrollment;
- •Unable to cooperate with cTACE and HAIC treatment;
- •Patients with primary malignant tumors other than hepatocellular carcinoma at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- •Clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or a history of myocardial infarction within the past 1 year;
- •Neurological or mental abnormalities that affect cognitive ability, including central nervous system transfer;
- •There were active serious clinical infections (>grade 2 NCI-CTCAE version 4.0), including active tuberculosis within 14 days before enrollment;
- •Known or self-reported HIV infection;
- •Uncontrolled systemic diseases, such as poorly controlled diabetes;
- •Known to have hypersensitivity or allergic reactions to any component of the study drug;
- •Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding
研究组 & 干预措施
cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody
patients will receive the combination treatment of cTACE/DEB-TACE plus HAIC and combined with regorafenib and anti-PD1 antibody or not. The anti-PD-1 antibody will be used depended on the contraindications or wishes of patients.
干预措施: Regorafenib (Drug)
cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody
patients will receive the combination treatment of cTACE/DEB-TACE plus HAIC and combined with regorafenib and anti-PD1 antibody or not. The anti-PD-1 antibody will be used depended on the contraindications or wishes of patients.
干预措施: cTACE/DEB-TACE-HAIC (Device)
结局指标
主要结局
Progression free overall survival，PFS
时间窗: 12 months
PFS was defined as the interval between the time at which treatment was initiated and intrahepatic tumor and/or extrahepatic tumor progression, symptomatic progression, including massive ascites and liver function that was categorized as Child-Pugh grade C, or death from any cause
Objective response rate, ORR
时间窗: 6 months
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate
Overall survival，OS
时间窗: 24 months
overall survival (OS) was defined as the interval between the time at which treatment was initiated and death or the last follow-up assessment
次要结局
- Disease control rate, DCR(6 months)
研究者
Zhu Xu
Hospital Chief Physician，MD
Peking University Cancer Hospital & Institute