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Trial 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
NCT ID:
NCT06644937
Condition:
Hepatocellular Carcinoma (HCC)
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Conditions: Keywords:
hepatocellular carcinoma,RFS,adjuvant therapy after surgery
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TACE combined with Acoradine
Description:
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) .
Arm group label:
TACE combination with Acoradine
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
Criteria for 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 (> 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
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 9, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Zhujiang Hospital
Agency class:
Other
Source:
Zhujiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06644937
