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Unresectable Hepatocellular CarcinomaPhase 1/2NCT06896396

Icaritin Soft Capsules+TACE+Immunotherapy+Targeted Therapy Versus TACE+Immunotherapy+Targeted Therapy for Unresectable Hepatocellular Carcinoma

A Phase 1/2 study testing Lenvatinib, Pembrolizumab, Icaritin soft capsules and TACE in people with Unresectable Hepatocellular Carcinoma, run by Zhiyong Huang at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors and the leading cause of cancer-related death worldwide. Surgical resection has always been the best hope for long-term survival of patients with HCC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Unresectable Hepatocellular Carcinoma
What is being tested?
Lenvatinib, Pembrolizumab, Icaritin soft capsules and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Apr 2025to 1 Feb 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Age range: 18-75 years old; 2) Patients diagnosed with hepatocellular carcinoma or cirrhosis through histology/cytology meet the clinical diagnostic criteria for hepatocellular carcinoma by the American Association for the Study of the Liver (AASLD). The clinical diagnostic criteria refer to the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)"; 3) Advanced primary liver cancer patients who have not received systematic treatment in the past or advanced liver cancer patients who have not received systematic treatment and have relapsed after radical resection; 4) Diseases are not suitable for radical surgery, transplantation, or ablation, but diseases are suitable for TACE treatment 5) At least one measurable lesion. Single tumor, diameter ≤ 10.0cm or multiple tumors; Number ≤ 10; The tumor burden of the lesion is less than 50%; 6) ECOG score 0-1 points; 7) Child Pugh liver function grade A; 8) Expected lifespan ≥ 3 months; 9) Blood, liver, and kidney function meet the following criteria:
  • Absolute neutrophil count ≥ 1.0 × 109/L;
  • Platelet count ≥ 75 × 109/L;
  • Hemoglobin concentration ≥ 90g/L;
  • Serum albumin concentration ≥ 28g/L;
  • Serum total bilirubin ≤ 3 x upper limit of normal (ULN);
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  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN;
  • The prothrombin time extension shall not exceed ULN6s;
  • Creatinine<1.5 × ULN or creatinine clearance rate (CrCl)>60 mL/min (Cockcroft Gault formula); 10) If the patient is HBsAg positive, HBV-DNA should be below 2000 IU/ml (10000 copies/ml) during treatment; 11) Women with fertility must undergo a negative pregnancy test; 12) Acceptable contraceptive methods must be used during the research period; 13) Can understand and be willing to sign a written informed consent form; 14) Capable of swallowing and absorbing oral pills; 15) Use up to 3 types of antihypertensive drugs to fully control blood pressure, defined as systolic/diastolic blood pressure ≤ 150/90 mmHg during screening, and no change in antihypertensive treatment within the first week/week prior to the first cycle.

Who cannot join

  • 1) Diffuse infiltrative lesions of the liver and brain metastases; 2) There are TACE contraindications, such as portosystemic shunt, hepatic blood flow and obvious atherosclerosis; 3) Individuals allergic to intravenous contrast agents; 4) Local treatment has been performed on existing lesions (e.g.: TACE、 Melting, particles TARE、 Hepatic artery infusion chemotherapy or radiotherapy); 5) The subject is unable to undergo enhanced liver CT or MRI scans; 6) Previous history of liver transplantation or current candidate for liver transplantation; 7) Pregnant, lactating women or participants planning to undergo contraceptive procedures within 2 years; 8) Patients with combined HIV and syphilis infections; 9) Patients with other concurrent malignant tumors or other malignant tumors within the first 5 years of enrollment; 10) Patients with severe functional impairments of the heart, kidneys, and other organs; 11) Severe clinical active infection>Level 2 (NCI-CTC version 5.0); 12) Mental illness patients who may affect the informed consent process; The patient is unable to take oral medication; The patient participated in clinical trials of other drugs within 12 months prior to enrollment.
  • 13) Patients who have experienced esophageal or gastric variceal rupture bleeding within the past 3 months, or have unconfirmed severe varices and are at high risk; 14) Has bleeding or thrombotic disease or is undergoing thrombolytic therapy; 15) Clinical significant hemoptysis or tumor bleeding for any reason within 2 weeks prior to the first administration of the study intervention; 16) Major cardiovascular damage within the 12 months prior to the first administration of the investigational drug, such as a history of NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction or cerebrovascular accident stroke, or arrhythmia related to hemodynamic instability; 17) There is clinically significant ascites during physical examination, which cannot be controlled with medication; 18) History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barr é syndrome, or multiple sclerosis 19) Idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, or history of idiopathic pneumonia, or evidence of active pneumonia on chest CT scan during screening 20) Known to be allergic to any component of the investigational drug formulation; 21) Other situations where the researcher deems it inappropriate to participate in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Tongji Hospital

    Wuhan, Hubei, 430030

    huang zhiyong, 13995507729, Zyhuang126@126.com

Other trials in China

About this study

Official title: Icaritin Soft Capsules and TACE Combined with Immunotherapy and Targeted Therapy Versus TACE Combined with Immunotherapy and Targeted Therapy for Unresectable Hepatocellular Carcinoma:a Prospective, Double-arm, Exploratory Study

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors and the leading cause of cancer-related death worldwide. Surgical resection has always been the best hope for long-term survival of patients with HCC. However, only a few patients have the opportunity to undergo surgery, and more than 70% of HCC patients have lost the opportunity of surgery at the time of diagnosis. The treatment measures for these patients are mainly transcatheter arterial chemoembolization and systemic therapy. In recent years, systemic therapies represented by targeted therapy and immunotherapy have made important progress in the field of liver cancer, improving the survival of patients with advanced unresectable HCC. Icaritin soft capsule is a monomer compound extracted, isolated, purified and enzymatically hydrolyzed from the natural medicinal plant Epimedium. It was approved for marketing on January 10, 2022 for patients with advanced first-line HCC. Icaritin soft capsules have the potential to delay TKI resistance and enhance the efficacy of PD-1 inhibitors. The aim of this study is to explore whetherIcaritin soft capsules and TACE combined with Immunotherapy and Targeted Therapy can improve the therapeutic effect of advanced HCC, ultimately prolong the survival time of patients, and provide a new treatment direction for patients with advanced HCC.

Being tested
Lenvatinib, Pembrolizumab, Icaritin soft capsules, TACE

What participants receive

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

  • Lenvatinib, PembrolizumabDrug

    Pabilizumab: intravenously every three weeks Lenvatinib, with a dosage based on body weight: 8 mg (≤60 kg) or 12 mg (>60 kg), once daily

  • Icaritin soft capsulesDrug

    Starting 3-5 days after the first TACE treatment, take 6 capsules orally, twice a day, and swallow them with warm water within 30 minutes after breakfast and dinner

  • TACEProcedure or surgery

    TACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2023 Edition).

Study groups in NCT06896396
Study groupRoleWhat they receive
Icaritin soft capsules+TACE+Immunotherapy+Targeted TherapyExperimentalIcaritin soft capsules,lenvatinib and pabilizumab were started 3-5 days after the first TACE treatment
Receives: Drug: Lenvatinib, Pembrolizumab; Drug: Icaritin soft capsules; Procedure: TACE
TACE+Immunotherapy+Targeted TherapyActive comparatorlenvatinib and pabilizumab were started 3-5 days after the first TACE treatment
Receives: Drug: Lenvatinib, Pembrolizumab; Procedure: TACE

What is being measured

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

  1. Progression Free Survival (PFS)

    PFS refers to the time from subject enrollment to disease progression according the Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) or death

    Measured: 12 month

Secondary outcomes (3)
  1. Objective Response Rate (ORR)

    ORR refers to the proportion of patients whose tumors shrink to a certain amount and maintain for a certain period of time (6 weeks after first dose of Durvalumab), including CR+PR cases. CR (complete response): disappearance of all target lesions, PR (partial response): reduction of the sum of the length and diameter of the baseline lesions by ≥30%.

    Measured: 6 weeks after the first TACE surgery

  2. Overall Survival (OS)

    OS was defined as time from diagnosis to death from any cause or the last follow-up

    Measured: 18 months

  3. Duration of Response(DOR)

    It refers to the time from the first evaluation of the tumor as CR or PR to the first evaluation as PD or death from any cause

    Measured: 18 months

Timeline

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

  1. First posted26 Mar 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Feb 2028 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06896396
Sponsor's protocol ID
uHCC-AKLD-TJ01
Status last verified
Mar 2025
First submitted
20 Mar 2025
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenvatinib, Pembrolizumab, Icaritin soft capsules and TACE in people with Unresectable Hepatocellular Carcinoma, run by Zhiyong Huang 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 9 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Mar 2025. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact huang zhiyong (86-13995507729, Zyhuang126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 12 month). 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 26 Mar 2025.

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