Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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In this study, patients with hepatocellular carcinoma were used as the research object to explore the effectiveness and safety of idarubicin hepatic artery perfusion combined with lipiodol embolization, and to preliminarily explore the possibility of idarubicin in the treatment of hepatocellular carcinoma. Provide evidence-based medicine for the discovery of better TACE combined chemotherapy regimens for the treatment of hepatocellular carcinoma.

Detailed Description
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China is a country with a high incidence of liver cancer, the annual incidence of nearly 50% of the world. At present, transcatheter Arterial chemoembolization (TACE) has become one of the main treatment methods for primary liver cancer and liver metastasis, and has been recognized as the first choice for inoperable primary liver cancer. In addition, it has also been applied in the treatment of resectable liver cancer, liver cancer with tumor embolus and liver metastasis, which is safe and reliable. Idarubicin is a DNA topoisomerase II inhibitor that promotes DNA strand breakage, trapping cells in the G2 phase of the cell cycle, DNA cleavage, and cell apoptosis. At the same time, it can be inserted between the DNA base pairs and create freedom. Preclinical studies have shown that Idarubicin has superior antitumor activity than epirubicin, especially against SUN-449 human hepatoma cells. In recent years, foreign scholars have conducted a series of explorations in the treatment of hepatocellular carcinoma with Idarubicin TACE, and have obtained positive results. This study aims to evaluate the safety and effectiveness of idarubicin lipiodol emulsion hepatic artery chemoembolization in the treatment of hepatocellular carcinoma, in order to provide evidence-based medical evidence for the discovery of a better TACE treatment regimen for advanced hepatocellular carcinoma.

Official Title
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A Randomized Controlled, Multi-center Clinical Study of Anbijian (Idarubicin Hydrochloride for Injection) vs. Epirubicin Lipiodol Emulsion Transhepatic Arterial Chemoembolization in the Treatment of Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Idarubicin Hydrochloride for Injection
* Drug: Epirubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old, no gender limit; Confirmed as hepatocellular carcinoma by histopathology or clinical diagnosis; The expected survival period is ≥3 months; Chinese liver cancer staging program (CNLC) IIb/IIIa, liver function Child pugh A or B, or Surgical resection, but due to other reasons (such as advanced age, severe liver cirrhosis, etc.) unable or unwilling to receive surgical treatment CNLC stage Ib and IIa liver cancer patients; ECOG score 0-1 points; At least one measurable lesion (spiral CT scan ≥10mm); Laboratory inspection indicators meet the following requirements: Peripheral blood: WBC≥4.0×109/L，PLT≥80×109/L，Hb≥90g/L. Renal function: Cr≤2.0×UNL (upper limit of normal); Liver function: BIL≤2.0×UNL (upper limit of normal), ALT/AST≤5.0×UNL (upper limit of normal) . Exclusion Criteria: Have received interventional therapy for liver cancer (except cryotherapy, radio frequency and microwave); The coagulation function is severely decreased and cannot be corrected; The main portal vein is completely embolized by cancer embolism, and the formation of collateral vessels is few; Patients with active hepatitis or severe infection who cannot be treated at the same time; Patients with cachexia or multiple organ failure;Persons with uncontrollable neurological or mental diseases or mental disorders, poor compliance, unable to cooperate and describe the treatment response; primary brain tumors or central nerve metastases have not been controlled, and have obvious intracranial hypertension or neuropsychiatric symptoms ; Pregnant or lactating women; Received other clinical trial drug treatments in the past 4 weeks; Allergy to any test drug or mannitol (excipient); Other situations where the investigator believes that the patient should not participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idarubicin<br>10mg idarubicin is dissolved in 5ml water for injection, and 5 20ml lipiodol is used to prepare lipiodol emulsion. | Drug: Idarubicin Hydrochloride for Injection<br>* After an interventional treatment, CT and/or MRI, tumor-related markers, liver and kidney function and blood routine examinations will be reviewed every 4-6 weeks, based on the patient's response to the last treatment, changes in liver function and physical fitness, and CT And (or) dynamic enhanced MRI scan to evaluate the survival of liver tumors and determine the next TACE treatment. At least 2 cycles are applied and no more than 4 cycles are applied.<br>* Other names: Anbijian;|
| Active Comparator: Epirubicin<br>50mg epirubicin is dissolved in 5ml 5% glucose solution, and 5 20ml lipiodol is used to prepare lipiodol emulsion. | Drug: Epirubicin<br>* After an interventional treatment, CT and/or MRI, tumor-related markers, liver and kidney function and blood routine examinations will be reviewed every 4-6 weeks, based on the patient's response to the last treatment, changes in liver function and physical fitness, and CT And (or) dynamic enhanced MRI scan to evaluate the survival of liver tumors and determine the next TACE treatment. At least 2 cycles are applied and no more than 4 cycles are applied.<br>* Other names: Epirubicin Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate, ORR | The number of cases that achieved complete remission (CR) or partial remission (PR) accounted for the percentage of patients with evaluable efficacy. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate, DCR | The number of complete remission (CR), partial remission (PR) and stable disease (SD) cases accounted for the percentage of patients with evaluable efficacy. | 24 months | 
| Survival rate | After a period of follow-up, the proportion of patients who are still alive. Observation in this study 1-year survival rate and 2-year survival rate | 24 months | 
| Time to progress, TTP | Time from start of TACE treatment to disease progression | 24 months | 
| Overall survival, OS | Time from the start of TACE treatment to death from any cause | 24 months |