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Hepatocellular CarcinomaPhase 2NCT05903456

Icaritin Soft Capsule Combined With Lenvatinib and TACE for the Treatment of Hepatocellular Carcinoma

A Phase 2 study testing TACE（transcatheter arterial chemoembolization）, lenvatinib and Icaritin soft capsules in people with Hepatocellular Carcinoma, run by Zhejiang Cancer Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators design a phase II clinical study to explore the efficacy and safety of Transarterial Chemoembolization (TACE) + Lenvatinib + Icaritin soft capsules in patients with Unresectable, non-metastatic hepatocellular carcinoma and to analyze potential biomarkers of therapeutic response. 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?
TACE（transcatheter arterial chemoembolization）, lenvatinib and Icaritin soft capsules
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jul 2023to Dec 2025
Phase
Phase 2
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

  • Between the ages of 18 and 80;
  • Patients with histological/cytological confirmed hepatocellular carcinoma.
  • HCC patients eligible for China liver cancer staging (CNLC) Stage IIIa, which cannot be resectable, are not suitable for radical treatment.
  • According to the RECIST v1.1 standard, there must be at least one measurable lesion on the upper abdominal enhanced CT or MRI.
  • Child-Pugh grade A or B;
  • ECOG physical condition score is 0 or 1;
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  • Suitable for the indications of TACE surgery and chemotherapy drugs prescribed in advance by the research center, without any contraindications.
  • Regular antiviral therapy should be given if HBV or HCV infection is present.
  • Life expectancy is more than 3 months
  • Able to swallow and absorb oral tablets;
  • Appropriate organ function with the following laboratory test values obtained within 7 days prior to therapeutic use:
  • (hemoglobin value ≥80g/L, neutrophil count ≥2.5×109/L, platelet count ≥75×109/L, serum total bilirubin ≤2× upper limit of normal (UNL), aspartic transferase ≤2×UNL, alanine transferase ≤3×UNL, serum creatinine ≤1.5×UNL)
  • Manageable blood pressure
  • Women of childbearing age must already be using reliable contraception or have had a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an effective method of contraception during the trial period and within 2 months after the last drug administration. Male subjects whose partners are women of childbearing age should use effective methods of contraception during the trial period and within 2 months after the last dose;
  • The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Who cannot join

  • Formation of portal vein main cancer thrombus or extensive cancer thrombus.
  • HCC was treated with local treatment of existing lesions (e.g., TACE, ablation, particle, TARE, hepatic arterial infusion chemotherapy, or radiotherapy).
  • Patients who have previously received targeted or immunoreactive anti-tumor therapy for HCC and chemotherapy need to be desensitized for more than one month.
  • Subjects were unable to perform enhanced CT or MRI scans of the liver.
  • Have a history of liver transplantation or are currently candidates for liver transplantation.
  • Patients at high risk for esophageal or gastric variceal bleeding or unproven severe variceal bleeding within the last 3 months.
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  • Have bleeding or thrombotic disease or are receiving thrombolytic therapy
  • Study clinically significant hemoptysis or tumor hemorrhage of any cause within 2 weeks prior to initial administration of the intervention.
  • Study of significant cardiovascular impairment in the 12 months prior to initial administration, such as a history of congestive heart failure above NYHA Grade II (Appendix 12), unstable angina, myocardial infarction or cerebrovascular stroke, or arrhythmias associated with hemodynamic instability.
  • There was clinically significant ascites on physical examination, which could not be controlled by drugs.
  • Known to be allergic to any component of icartin soft capsules and lenvatinib preparation.
  • Pregnant or lactating female patients.
  • Other conditions in which participation in the study is not appropriate according to the investigator's judgment.

Trial locations and contacts

No sites are listed yet.

guoliang Shao, doctor contact

13958183472

shaogl@zjcc.org.cn

About this study

Official title: Icaritin Soft Capsule Combined With Lenvatinib and Transcatheter Arterial Chemoembolization（TACE） for the Treatment of Hepatocellular Carcinomaunresectable, Non-metastatic Hepatocellular Carcinoma

The investigators design a phase II clinical study to explore the efficacy and safety of Transarterial Chemoembolization (TACE) + Lenvatinib + Icaritin soft capsules in patients with Unresectable, non-metastatic hepatocellular carcinoma and to analyze potential biomarkers of therapeutic response.

Read the detailed description

This is a single-center, open-label, prospective, non-randomized clinical trial. We adopted the prospective cohort study to explore the safety and efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Icaritin soft capsules in the patients with Unresectable, non-metastatic hepatocellular carcinoma.

It is estimated that 20 patients who met the study criteria will be enrolled in Zhejiang Cancer Hospital. The investigators will follow up and collect subjects' data monthly to evaluate the efficacy and safety of treatment, including overall survival and time to progression. Multi-omics data analysis will be used to find potential biomarkers of treatment response.

Being tested
TACE（transcatheter arterial chemoembolization）, lenvatinib, Icaritin soft capsules
Keywords
Hepatocellular carcinoma; Icaritin soft capsules;TACE; lenvatinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TACE（transcatheter arterial chemoembolization）Procedure or surgery

    TACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2018 Edition).

    The patients with HCC were selected according to the inclusion criteria (referring to the conditions of the subjects). The subjects who met the inclusion criteria could enter the study after they signed the informed consent. 4-6 weeks after the first TACE treatment, the resectability criteria were evaluated. If not, the next cycle of TACE treatment was carried out. The general principle is to reduce the number of interventional treatment and extend the interval of interventional operation as far as possible under the condition of controlling the tumor and the survival of patients with tumor.

  • lenvatinibDrug

    Also called target drug

    Ronvastinib is an orally administered multi-receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activity of vascular endothelial growth factor (VEGF) receptors, such as VEGF-1, VEGF-2, and VEGF-3, in addition to inhibiting other pro-angiogenic and oncogenic signaling pathways associated with tumor proliferation ，has been approved as a first-line treatment for liver cancer

  • Icaritin soft capsulesDrug

    Also called Small molecule immunomodulator

    Icaritin soft capsule is a flavonoid compound extracted from traditional Chinese medicinal materials. It is a new type of small molecule immunomodulator. It is a 1.2 class of innovative Chinese medicine with global independent intellectual property rights. By inhibiting inflammatory signaling pathway and reducing the release of inflammatory factors, the immune microenvironment can be regulated to play an anti-tumor role. At present, it has been approved for first-line treatment of advanced liver cancer, with good efficacy and safety.

Study groups in NCT05903456
Study groupRoleWhat they receive
TACE +lenvatinib+Icaritin soft capsulesExperimentalTrial drug Lenvatinib, 8mg (2 tablets for patients weighing less than 60kg), or 12mg (3 tablets for patients weighing more than 60kg), once daily. Icariin Soft Capsules 1200 mg/d (6 tablets in two doses) should be swallowed with warm water within 30 minutes after meal. Take lenvatinib and Icaritin soft capsules 3 to 5 days after TACE. Until the disease progresses or the patient becomes intolerant.
Receives: Procedure: TACE（transcatheter arterial chemoembolization）; Drug: lenvatinib; Drug: Icaritin soft capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    It was defined as the percentage of patients with complete response (CR) and partial response (PR) in all patients, and the treatment response was based on the modified response evaluation criteria in solid tumors (recist1.1)

    Measured: 48 weeks

Secondary outcomes (5)

  1. progression-free survival

    It was defined as the time from successful hepatectomy to recurrence. Patients who withdraw or lose follow-up will be treated as deletion

    Measured: 96 weeks

  2. Overall Survival

    It was defined as the time from the beginning of treatment to death from any cause throughout the trial. Patients who dropped out or lost follow-up will be treated as deletion, and the known last survival date will be regarded as the last survival time. Patients who survived at the end of the study will also be treated as deletions, and the last known date of survival will be taken as the final survival time

    Measured: 96 weeks

  3. Disease Control Rate

    It was defined as the Proportion of all subjects receiving study therapy who rated complete response (CR), partial response (PR), and stable disease (SD) as best overall response according to RECIST 1.1 criteria.

    Measured: 48 weeks

  4. Duration of Response

    It was defined as the period from the date when tumor response was first recorded (as measured by RECIST 1.1 criteria) to the date when objective tumor progression was first recorded (as measured by RECIST 1.1 criteria) or the date of death from any cause.

    Measured: up to 48 weeks

  5. adverse event

    The incidence, severity, and serious adverse events associated with medication use were determined by NCI CTCAE v5.0 standards

    Measured: 96 weekes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05903456
Sponsor's protocol ID
IRB-2022-802
Status last verified
Jun 2023
First submitted
19 May 2023
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TACE（transcatheter arterial chemoembolization）, lenvatinib and Icaritin soft capsules in people with Hepatocellular Carcinoma, run by Zhejiang Cancer Hospital.

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 15 inclusion and 13 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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, doctor (13958183472, shaogl@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05903456.

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 15 Jun 2023.

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