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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
TACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2018 Edition). The patients with HCC were selected according to the inclusion criteria (referring to the conditions of the subjects). The subjects who met the inclusion criteria could enter the study after they signed the informed consent. 4-6 weeks after the first TACE treatment, the resectability criteria were evaluated. If not, the next cycle of TACE treatment was carried out. The general principle is to reduce the number of interventional treatment and extend the interval of interventional operation as far as possible under the condition of controlling the tumor and the survival of patients with tumor.
Ronvastinib is an orally administered multi-receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activity of vascular endothelial growth factor (VEGF) receptors, such as VEGF-1, VEGF-2, and VEGF-3, in addition to inhibiting other pro-angiogenic and oncogenic signaling pathways associated with tumor proliferation ,has been approved as a first-line treatment for liver cancer
Objective Response Rate
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)
Time frame: 48 weeks
progression-free survival
It was defined as the time from successful hepatectomy to recurrence. Patients who withdraw or lose follow-up will be treated as deletion
Time frame: 96 weeks
Overall Survival
It was defined as the time from the beginning of treatment to death from any cause throughout the trial. Patients who dropped out or lost follow-up will be treated as deletion, and the known last survival date will be regarded as the last survival time. Patients who survived at the end of the study will also be treated as deletions, and the last known date of survival will be taken as the final survival time
Time frame: 96 weeks
Disease Control Rate
It was defined as the Proportion of all subjects receiving study therapy who rated complete response (CR), partial response (PR), and stable disease (SD) as best overall response according to RECIST 1.1 criteria.
Time frame: 48 weeks
Duration of Response
It was defined as the period from the date when tumor response was first recorded (as measured by RECIST 1.1 criteria) to the date when objective tumor progression was first recorded (as measured by RECIST 1.1 criteria) or the date of death from any cause.
Time frame: up to 48 weeks
adverse event
The incidence, severity, and serious adverse events associated with medication use were determined by NCI CTCAE v5.0 standards
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Icaritin soft capsule is a flavonoid compound extracted from traditional Chinese medicinal materials. It is a new type of small molecule immunomodulator. It is a 1.2 class of innovative Chinese medicine with global independent intellectual property rights. By inhibiting inflammatory signaling pathway and reducing the release of inflammatory factors, the immune microenvironment can be regulated to play an anti-tumor role. At present, it has been approved for first-line treatment of advanced liver cancer, with good efficacy and safety.
Time frame: 96 weekes