Clinical trial NCT06644937: Single-arm Clinical Trial of TACE in Combination With Acoradine as Adjuvant Therapy After Surgery in Patients With Hepatocellular Carcinoma at High Risk of Recurrence
Official title: Single-arm Clinical Trial of TACE in Combination With Acoradine as Adjuvant Therapy After Surgery in Patients With Hepatocellular Carcinoma at High Risk of Recurrence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: hepatocellular carcinoma,RFS,adjuvant therapy after surgery
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Acoradine


Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily cooperated with the study and signed the informed consent,
2. Male or female, 18 years old ≤ age ≤75 years old,
3. The histopathologic diagnosis was hepatocellular carcinoma
4. 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)
5. To satisfy any of the following high risk factors for postoperative recurrence of hepatocellular carcinoma:

   I) BCLC stage B (\&gt; 3 tumors, regardless of size or number, at least one of which is \&gt; 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
6. ECOG performance status score of 0-1 and Child-Pugh score of 5-6
7. 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) .
8. 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:

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

Primary outcomes:
measure: 1 year recurrence-free survival rate ,1-year RFSR.
timeFrame: 1 year
Secondary outcomes:
measure: TTR( time to recurrence)
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
References: