Icaritin Soft Capsule Combined With Lenvatinib and Transcatheter Arterial Chemoembolization（TACE） for the Treatment of Hepatocellular Carcinomaunresectable, Non-metastatic Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Objective Response Rate
研究概览
简要总结
The investigators design a phase II clinical study to explore the efficacy and safety of Transarterial Chemoembolization (TACE) + Lenvatinib + Icaritin soft capsules in patients with Unresectable, non-metastatic hepatocellular carcinoma and to analyze potential biomarkers of therapeutic response.
详细描述
This is a single-center, open-label, prospective, non-randomized clinical trial. We adopted the prospective cohort study to explore the safety and efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Icaritin soft capsules in the patients with Unresectable, non-metastatic hepatocellular carcinoma.
It is estimated that 20 patients who met the study criteria will be enrolled in Zhejiang Cancer Hospital. The investigators will follow up and collect subjects' data monthly to evaluate the efficacy and safety of treatment, including overall survival and time to progression. Multi-omics data analysis will be used to find potential biomarkers of treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
NO masking
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 80;
- •Patients with histological/cytological confirmed hepatocellular carcinoma.
- •HCC patients eligible for China liver cancer staging (CNLC) Stage IIIa, which cannot be resectable, are not suitable for radical treatment.
- •According to the RECIST v1.1 standard, there must be at least one measurable lesion on the upper abdominal enhanced CT or MRI.
- •Child-Pugh grade A or B;
- •ECOG physical condition score is 0 or 1;
- •Suitable for the indications of TACE surgery and chemotherapy drugs prescribed in advance by the research center, without any contraindications.
- •Regular antiviral therapy should be given if HBV or HCV infection is present.
- •Life expectancy is more than 3 months
- •Able to swallow and absorb oral tablets;
- •Appropriate organ function with the following laboratory test values obtained within 7 days prior to therapeutic use:
- •(hemoglobin value ≥80g/L, neutrophil count ≥2.5×109/L, platelet count ≥75×109/L, serum total bilirubin ≤2× upper limit of normal (UNL), aspartic transferase ≤2×UNL, alanine transferase ≤3×UNL, serum creatinine ≤1.5×UNL)
- •Manageable blood pressure
- •Women of childbearing age must already be using reliable contraception or have had a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an effective method of contraception during the trial period and within 2 months after the last drug administration. Male subjects whose partners are women of childbearing age should use effective methods of contraception during the trial period and within 2 months after the last dose;
- •The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
排除标准
- •Formation of portal vein main cancer thrombus or extensive cancer thrombus.
- •HCC was treated with local treatment of existing lesions (e.g., TACE, ablation, particle, TARE, hepatic arterial infusion chemotherapy, or radiotherapy).
- •Patients who have previously received targeted or immunoreactive anti-tumor therapy for HCC and chemotherapy need to be desensitized for more than one month.
- •Subjects were unable to perform enhanced CT or MRI scans of the liver.
- •Have a history of liver transplantation or are currently candidates for liver transplantation.
- •Patients at high risk for esophageal or gastric variceal bleeding or unproven severe variceal bleeding within the last 3 months.
- •Have bleeding or thrombotic disease or are receiving thrombolytic therapy
- •Study clinically significant hemoptysis or tumor hemorrhage of any cause within 2 weeks prior to initial administration of the intervention.
- •Study of significant cardiovascular impairment in the 12 months prior to initial administration, such as a history of congestive heart failure above NYHA Grade II (Appendix 12), unstable angina, myocardial infarction or cerebrovascular stroke, or arrhythmias associated with hemodynamic instability.
- •There was clinically significant ascites on physical examination, which could not be controlled by drugs.
- •Known to be allergic to any component of icartin soft capsules and lenvatinib preparation.
- •Pregnant or lactating female patients.
- •Other conditions in which participation in the study is not appropriate according to the investigator's judgment.
研究组 & 干预措施
TACE +lenvatinib+Icaritin soft capsules
Trial drug Lenvatinib, 8mg (2 tablets for patients weighing less than 60kg), or 12mg (3 tablets for patients weighing more than 60kg), once daily. Icariin Soft Capsules 1200 mg/d (6 tablets in two doses) should be swallowed with warm water within 30 minutes after meal. Take lenvatinib and Icaritin soft capsules 3 to 5 days after TACE. Until the disease progresses or the patient becomes intolerant.
干预措施: TACE（transcatheter arterial chemoembolization） (Procedure)
TACE +lenvatinib+Icaritin soft capsules
Trial drug Lenvatinib, 8mg (2 tablets for patients weighing less than 60kg), or 12mg (3 tablets for patients weighing more than 60kg), once daily. Icariin Soft Capsules 1200 mg/d (6 tablets in two doses) should be swallowed with warm water within 30 minutes after meal. Take lenvatinib and Icaritin soft capsules 3 to 5 days after TACE. Until the disease progresses or the patient becomes intolerant.
干预措施: lenvatinib (Drug)
TACE +lenvatinib+Icaritin soft capsules
Trial drug Lenvatinib, 8mg (2 tablets for patients weighing less than 60kg), or 12mg (3 tablets for patients weighing more than 60kg), once daily. Icariin Soft Capsules 1200 mg/d (6 tablets in two doses) should be swallowed with warm water within 30 minutes after meal. Take lenvatinib and Icaritin soft capsules 3 to 5 days after TACE. Until the disease progresses or the patient becomes intolerant.
干预措施: Icaritin soft capsules (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 48 weeks
It was defined as the percentage of patients with complete response (CR) and partial response (PR) in all patients, and the treatment response was based on the modified response evaluation criteria in solid tumors (recist1.1)
次要结局
- Duration of Response(up to 48 weeks)
- adverse event(96 weekes)
- progression-free survival(96 weeks)
- Overall Survival(96 weeks)
- Disease Control Rate(48 weeks)
研究者
Guoliang Shao
Chief Physician
Zhejiang Cancer Hospital