HCCPhase 2NCT06285149
Tace With Icaritin in First-line Treatment of Middle and Advanced HCC in Child Grade B Patients
A Phase 2 study testing Icaritin in people with HCC, run by Henan Cancer Hospital.
Trial summary
Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- Icaritin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCC was confirmed by histopathology or clinical diagnosis;
- No previous systematic therapy;
- Age 18-75 years old;
- CNLC: Ⅱb-Ⅲa stage;
- Child-Pugh grade B;
- ECOG PS score :0-1;
Show all 11Show fewer
- No major vessel invasion or distant metastasis;
- Suitable for interventional treatment;
- Measurable disease according to mRECIST;
- Willing to sign informed consent;
- Willing and able to follow study protocols and visit plans.
Who cannot join
- Patients who refuse or are not suitable for interventional treatment;
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology;
- Prior systematic therapy for HCC, including chemotherapy agents, sorafenib, Renvastinib, regorafenib and other targeted agents or immunomodulators such as anti-PD-1, anti-PD-L1, anti-CTLA-4, other than antiviral therapy for patients receiving any other investigational drug;
- Contraindications for interventional therapy, such as severe cirrhosis, more than moderate ascites, and Child C liver function; 5, diagnosed as hepatic encephalopathy, sclerosing cholangitis, Gilbert disease;
- 6. A history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within the previous 6 months; 7. Serious dysfunction of vital organs such as heart, brain and lungs; 8.uncontrolled high blood pressure, gastrointestinal bleeding or coagulation dysfunction, etc.; 9. Pregnant or nursing patients; 10. Allergic to drugs or excipients used in the study; 11. Other conditions deemed inappropriate for participation in the study by the investigator.
About this study
Official title: Prospective Single-arm, Single-center Exploratory Clinical Study on Efficacy and Safety of Interventional Therapy Combined With Icaritin in First-line Treatment of Middle and Advanced HCC in Child Grade B Patients
Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus, TACE+Icaritin may potentially optimize treatment strategies for patients with poor liver function reserve.
Read the detailed description
Child B patients have a lower tolerance to targeted immunotherapy, and combining interventional therapy with targeted immunotherapy can result in an accumulation of toxic side effects leading to disease progression. Additionally, repeated local interventions can further deteriorate liver function. These patients currently face limited treatment choices. Apatinib has minimal adverse reactions and has been recommended by experts as a level I option for Child B patients in the HCC 2022 CSCO guidelines. Therefore, combining interventional therapy with apatinib holds promise in improving survival outcomes for Child B patients.
- Conditions
- HCC
- Being tested
- Icaritin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcaritinDrug
This product is suitable for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse to receive standard treatment and have not received systemic treatment in the past, and the peripheral blood compound markers of patients meet at least two of the following detection indicatorsItem: AFP>400 ng/mL; TNF-a<2.5 pg/mL; IFN-y>7.0 pg/mL.The conditional approval is based on data from an interim analysis of an enriched population in a randomized controlled Phase 11 clinical trial, and full approval for this indication will be subject to confirmation of the clinical benefit of the product in planned confirmatory trials.
| Study group | Role | What they receive |
|---|---|---|
| 80 patients with advanced HCC in Child-Pugh B who had not been systematically | Experimental | Icaritin will be divided into the first dose group (200mg bid orally) using 3+3 dosage. The second dose group will be 400mg bid orally; And the third dose group, 600mg bid, taken orally. It is taken within 1 hour after a meal, and Icaritin will be administered continuously during interventional therapy. Receives: Drug: Icaritin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The proportion of patients with optimal response achieving complete or partial response
Measured: 2 years
PFS
If the patient has not progressed or died at the last follow-up, the date on which the clinician last confirmed that there was no tumor progression will prevail. For patients who are lost to follow-up, the date when the tumor was last recorded as not progressing will be considered. Patients who have started a new treatment prior to progression will have the date their tumor was last recorded prior to the new treatment.
Measured: 2 years
Secondary outcomes (1)
Overall survival，OS
If the patient is still alive at the last follow-up, the date of the clinician's last confirmation of the patient's survival shall prevail. For patients who were lost to follow-up, the date of last recorded patient survival was considered.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Henan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285149
- Sponsor's protocol ID
- AKLD-22
- Status last verified
- Dec 2023
- First submitted
- 22 Feb 2024
- Last updated
- 29 Feb 2024
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-arm, Single-center Exploratory Clinical Study on Efficacy and Safety of Interventional Therapy Combined With Icaritin in First-line Treatment of Middle and Advanced HCC in Child Grade B Patients
- ClinicalTrials.gov ID
- NCT06285149
- Acronym / sponsor ID
- AKLD-22
- Conditions
- HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Feb 2024 (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.
Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus, TACE+Icaritin may potentially optimize treatment strategies for patients with poor liver function reserve.
Detailed description
Child B patients have a lower tolerance to targeted immunotherapy, and combining interventional therapy with targeted immunotherapy can result in an accumulation of toxic side effects leading to disease progression. Additionally, repeated local interventions can further deteriorate liver function. These patients currently face limited treatment choices. Apatinib has minimal adverse reactions and has been recommended by experts as a level I option for Child B patients in the HCC 2022 CSCO guidelines. Therefore, combining interventional therapy with apatinib holds promise in improving survival outcomes for Child B patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 80 patients with advanced HCC in Child-Pugh B who had not been systematically | Experimental | Drug: IcaritinIcaritin will be divided into the first dose group (200mg bid orally) using 3+3 dosage. The second dose group will be 400mg bid orally; And the third dose group, 600mg bid, taken orally. It is taken within 1 hour after a meal, and Icaritin will be administered continuously during interventional therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HCC was confirmed by histopathology or clinical diagnosis;
- No previous systematic therapy;
- Age 18-75 years old;
- CNLC: Ⅱb-Ⅲa stage;
- Child-Pugh grade B;
Key exclusion criteria (5 listed)
- Patients who refuse or are not suitable for interventional treatment;
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology;
- Prior systematic therapy for HCC, including chemotherapy agents, sorafenib, Renvastinib, regorafenib and other targeted agents or immunomodulators such as anti-PD-1, anti-PD-L1, anti-CTLA-4, other than antiviral therapy for patients receiving any other investigational drug;
- Contraindications for interventional therapy, such as severe cirrhosis, more than moderate ascites, and Child C liver function; 5, diagnosed as hepatic encephalopathy, sclerosing cholangitis, Gilbert disease;
- 6. A history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within the previous 6 months; 7. Serious dysfunction of vital organs such as heart, brain and lungs; 8.uncontrolled high blood pressure, gastrointestinal bleeding or coagulation dysfunction, etc.; 9. Pregnant or nursing patients; 10. Allergic to drugs or excipients used in the study; 11. Other conditions deemed inappropriate for participation in the study by the investigator.
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 |
|---|---|---|
| IcaritinThis product is suitable for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse to receive standard treatment and have not received systemic treatment in the past, and the peripheral blood compound markers of patients meet at least two of the following detection indicatorsItem: AFP>400 ng/mL; TNF-a<2.5 pg/mL; IFN-y>7.0 pg/mL.The conditional approval is based on data from an interim analysis of an enriched population in a randomized controlled Phase 11 clinical trial, and full approval for this indication will be subject to confirmation of the clinical benefit of the product in planned confirmatory trials. | Drug | 80 patients with advanced HCC in Child-Pugh B who had not been systematically |
Primary outcome
ORR
Time frame: 2 years
The proportion of patients with optimal response achieving complete or partial response
PFS
Time frame: 2 years
If the patient has not progressed or died at the last follow-up, the date on which the clinician last confirmed that there was no tumor progression will prevail. For patients who are lost to follow-up, the date when the tumor was last recorded as not progressing will be considered. Patients who have started a new treatment prior to progression will have the date their tumor was last recorded prior to the new treatment.
1 secondary outcome
Overall survival，OS
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
Related trials for HCC
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
Not yet recruitingPhase 2
NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC
Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer
Not yet recruitingPhase 2
A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced or Metastatic Solid Tumors, NSCLC
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icaritin in people with HCC, run by Henan 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 11 inclusion and 5 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 29 Feb 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 2 years). The study lists 2 primary outcomes in all. 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 29 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.