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Recruiting NCT06644937

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

Phase II / Phase III Interventional Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TACE combined with Acoradine.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug TACE combined with Acoradine
    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) .

Primary outcome measures

  • 1 year recurrence-free survival rate ,1-year RFSR. [Time frame: 1 year]
Secondary outcome measures (1)
  • TTR( time to recurrence) [Time frame: 1year]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhujiang Hospital, Southern Medical University — Guangzhou

Identifiers

NCT: NCT06644937 · 2024-KY-281-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗