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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Unresectable Hepatocellular Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| Icaritin soft capsules+TACE+Immunotherapy+Targeted Therapy | Experimental | Icaritin 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 Therapy | Active comparator | lenvatinib 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.
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)
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
Overall Survival (OS)
OS was defined as time from diagnosis to death from any cause or the last follow-up
Measured: 18 months
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.
- First posted26 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiyong Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiyong Huang, Tongji Hospital
- Investigators
- huang zhiyong, Principal investigator, Tongji Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06896396
- Acronym / sponsor ID
- uHCC-AKLD-TJ01
- Conditions
- Unresectable Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhiyong HuangUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 26 Mar 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icaritin soft capsules+TACE+Immunotherapy+Targeted Therapy | Experimental | Drug: Lenvatinib, Pembrolizumab, Drug: Icaritin soft capsules, Procedure: TACEIcaritin soft capsules,lenvatinib and pabilizumab were started 3-5 days after the first TACE treatment |
| TACE+Immunotherapy+Targeted Therapy | Active comparator | Drug: Lenvatinib, Pembrolizumab, Procedure: TACElenvatinib and pabilizumab were started 3-5 days after the first TACE treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Lenvatinib, PembrolizumabPabilizumab: intravenously every three weeks Lenvatinib, with a dosage based on body weight: 8 mg (≤60 kg) or 12 mg (>60 kg), once daily | Drug | Icaritin soft capsules+TACE+Immunotherapy+Targeted Therapy, TACE+Immunotherapy+Targeted Therapy |
| Icaritin soft capsulesStarting 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 | Drug | Icaritin soft capsules+TACE+Immunotherapy+Targeted Therapy |
| TACETACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2023 Edition). | Procedure or surgery | Icaritin soft capsules+TACE+Immunotherapy+Targeted Therapy, TACE+Immunotherapy+Targeted Therapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: 12 month
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
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 6 weeks after the first TACE surgery
Overall Survival (OS)
Time frame: 18 months
Duration of Response(DOR)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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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.
huang zhiyong principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
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.