Clinical trial NCT05053386: Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate, ORR
timeFrame: 24 months
Secondary outcomes:
measure: disease control rate, DCR
timeFrame: 24 months
measure: Survival rate
timeFrame: 24 months
measure: Time to progress, TTP
timeFrame: 24 months
measure: Overall survival, OS
timeFrame: 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: