Single-arm Clinical Trial of TACE in Combination With Icaritin as Adjuvant Therapy After Surgery in Patients With Hepatocellular Carcinoma at High Risk of Recurrence

NCT06644937 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-KY-281-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To assess 1-year recurrence-free survival (RFS) in patients with hepatocellular carcinoma (HCC) who are at high risk of Inguinal orchiectomy recurrence usingTACE combined with icaritin

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

hepatocellular carcinoma; RFS; adjuvant therapy after surgery

Outcome Measures

Primary Outcomes (1)

• 1 year recurrence-free survival rate ,1-year RFSR.

  1 year recurrence-free survival rate ,1-year RFSR.

  1 year

Secondary Outcomes (1)

• TTR( time to recurrence)

  1year

Study Arms (1)

TACE combination with icaritin

EXPERIMENTAL

Drug: TACE combined with Acoradine

Interventions

TACE combined with Acoradine DRUG

Transcatheter hepatic arterial chemoembolization (TACE) : the treatment interval was 28 days, the window period was ± 7 days. Subjects received a maximum of 4 TACE treatments; reduced and delayed treatment: laboratory tests were performed before the start of each cycle of TACE, with investigator criteria confirming whether TACE treatment was feasible. Acoradine: 6 tablets bid, taken after meals for 6 months or until intolerable or progressive disease (starting one month after surgery) .

TACE combination with icaritin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily cooperated with the study and signed the informed consent,
• Male or female, 18 years old ≤ age ≤75 years old,
• The histopathologic diagnosis was hepatocellular carcinoma
• R0 resection was performed within 4 to 8 weeks before recruitment (patients who were confirmed to have R0 resection by imaging and pathological examination were excluded from the study group if the residual R1, residual R2 or the margin of resection were not clear)
• To satisfy any of the following high risk factors for postoperative recurrence of hepatocellular carcinoma:
• I) BCLC stage B (\> 3 tumors, regardless of size or number, at least one of which is \> 3 cm in diameter) ; ii) single tumor ≥5 cm in diameter; III) intraoperative or postoperative pathological findings of vascular invasion (including microvascular invasion and VP1/VP2 portal vein invasion) ; IV) histopathologic grade of low differentiation; v) capsular invasion or loss with unclear border; VI) direct invasion of adjacent organs
• ECOG performance status score of 0-1 and Child-Pugh score of 5-6
• None of the patients had received anti-tumor therapy for hepatocellular carcinoma, including systemic therapy and local therapy (except for 1-2 prophylactic TACE or HAIC 4-8 weeks after radical therapy) .
• Subjects who received radical therapy, if required, were allowed to receive 1-2 prophylactic TACE/Haic treatments 4-8 weeks after surgery (on demand and not necessarily)

You may not qualify if:

• Known sarcomatoid hepatocellular carcinoma/mixed hepatocellular carcinoma-cholangiocarcinoma/fibrolamellar hepatocellular carcinoma;
• A history of other malignancies in the past 5 years or at the same time;
• Severe functional impairment of other important organs such as heart, brain, lung and kidney;
• Patients with a history of immunodeficiency or autoimmune disease;
• Evidence of tumor recurrence or metastasis before enrollment;
• Known hypersensitivity to active ingredients, excipients, or history of severe allergy to any other monoclonal antibody, anti-angiogenic drugs;
• Patients with a history of hepatic encephalopathy;

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Shunjun Fu Fu Shunjun Fu, Prof.

CONTACT

15989187352; fsj103@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: November 29, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2025

Record last verified: 2024-09

Locations

CN (1)