Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 3:21 PM
Study NCT ID:
NCT05903456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-15
First Post:
2023-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Icaritin Soft Capsule Combined With Lenvatinib and TACE for the Treatment of Hepatocellular Carcinoma
Sponsor:
Zhejiang Cancer Hospital
Organization:
Study Overview
Official Title:
Icaritin Soft Capsule Combined With Lenvatinib and Transcatheter Arterial Chemoembolization（TACE） for the Treatment of Hepatocellular Carcinomaunresectable, Non-metastatic Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: