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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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)

Locations
Other Locations
China
Zhujiang Hospital, Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Shunjun Fu Fu Shunjun Fu, Prof.
fsj103@163.com
15989187352
Time Frame
Start Date: 2024-11-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: TACE combination with icaritin
Related Therapeutic Areas
Sponsors
Leads: Zhujiang Hospital

This content was sourced from clinicaltrials.gov