Hepatocellular CarcinomaNCT05053386
Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma
A study testing Idarubicin Hydrochloride for Injection and Epirubicin in people with Hepatocellular Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Idarubicin Hydrochloride for Injection and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Idarubicin Hydrochloride for Injection, Epirubicin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idarubicin Hydrochloride for InjectionDrug
Also called Anbijian
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.
EpirubicinDrug
Also called Epirubicin Hydrochloride
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.
| Study group | Role | What they receive |
|---|---|---|
| Idarubicin | Experimental | 10mg idarubicin is dissolved in 5ml water for injection, and 5~20ml lipiodol is used to prepare lipiodol emulsion. Receives: Drug: Idarubicin Hydrochloride for Injection |
| Epirubicin | Active comparator | 50mg epirubicin is dissolved in 5ml 5% glucose solution, and 5~20ml lipiodol is used to prepare lipiodol emulsion. Receives: Drug: Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 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
Measured: 24 months
Time to progress, TTP
Time from start of TACE treatment to disease progression
Measured: 24 months
Overall survival, OS
Time from the start of TACE treatment to death from any cause
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, guoliang shao, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053386
- Sponsor's protocol ID
- IRB-2021-208
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05053386
- Acronym / sponsor ID
- IRB-2021-208
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idarubicin | Experimental | Drug: Idarubicin Hydrochloride for Injection10mg idarubicin is dissolved in 5ml water for injection, and 5~20ml lipiodol is used to prepare lipiodol emulsion. |
| Epirubicin | Active comparator | Drug: Epirubicin50mg epirubicin is dissolved in 5ml 5% glucose solution, and 5~20ml lipiodol is used to prepare lipiodol emulsion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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) .
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Idarubicin Hydrochloride for InjectionAlso: AnbijianAfter 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. | Drug | Idarubicin |
| EpirubicinAlso: Epirubicin HydrochlorideAfter 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. | Drug | Epirubicin |
Primary outcome
Objective Response Rate, ORR
Time frame: 24 months
The number of cases that achieved complete remission (CR) or partial remission (PR) accounted for the percentage of patients with evaluable efficacy.
4 secondary outcomes
disease control rate, DCR
Time frame: 24 months
Survival rate
Time frame: 24 months
Time to progress, TTP
Time frame: 24 months
Overall survival, OS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Idarubicin Hydrochloride for Injection and Epirubicin in people with Hepatocellular Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact guoliang shao (13958183472, Shaoguoliang666@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate, ORR (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.