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New treatment option for Hepatocellular Carcinoma (HCC)
Official title 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
ClinicalTrials.gov ID: NCT06644937
What this study is testing
What is TACE combined with Acoradine?
TACE combined with Acoradine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The people 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...
- To satisfy any of the following high risk factors for postoperative recurrence of hepatocellular carcinoma: I) BCLC stage B (\> 3 tumors, regardless...
You likely can't join 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;
See the full eligibility criteria
- The people 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...
- 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)...
- 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) .
- people 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)
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.