Hepatocellular CarcinomaPhase 3BESTPOPNCT05594927
Icaritin Soft Capsule Versus Huachansu Tablet in the First-line Treatment of Unresectable Hepatocellular Carcinoma With Poor Conditions and Biomarker Enrichment (Biomarker Enrichment Study of Poor Prognosis HCC Patients, BESTPOP)
A Phase 3 study testing Icaritin and Huachansu in people with Hepatocellular Carcinoma, run by Beijing Shenogen Biomedical Co., Ltd at 3 sites in China.
Trial summary
A study to evaluate the efficacy and safety of icaritin versus huachansu in the first-line treatment of unresectable hepatocellular carcinoma with poor conditions and biomarker enrichment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Icaritin and Huachansu
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 3 sitesChina
- Study dates
- 12 Dec 2022to 30 Aug 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years and older;
- HCC patients who meet the clinical diagnostic criteria of the Chinese Diagnosis and Treatment Guideline of Primary Liver Cancer (2022 edition), and/or with diagnosis confirmed histopathologically/cytologically;
- Unresectable HCC patients;
- Patients with a peripheral blood composite biomarker Score ≥ 2 points, 1 point each for AFP ≥ 400 ng/mL, TNF-α < 2.5 pg/mL, and IFN-γ ≥ 7.0 pg/mL ;
- No prior first-line systemic treatment for HCC, including sorafenib, lenvatinib, donafenib, atezolizumab plus bevacizumab, sintilimab plus a bevacizumab biosimilar, camrelizumab plus apatinib, and durvalumab plus tremelimumab, oxaliplatin-based systemic chemotherapy (FOLFOX4) , icaritin, huachansu, and other anti-cancer drugs such as targeted agents, immune checkpoint inhibitors, and systemic chemotherapy;
- Child-Pugh score ≤ 7;
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- Vital organ functions should meet the following requirements:
- ① Hematopoietic function: platelet ≥ 40×10^9/L, hemoglobin ≥ 80 g/L, white blood cell ≥ 2.0×10^9/L;
- ② Liver function: total bilirubin ≤ 1.5 times upper limit of normal (ULN) , alanine Aminotransferase (ALT) and aspartate Aminotransferase (AST) ≤ 5×ULN; albumin ≥ 28 g/L;
- ③ Renal function: Serum Creatinine ≤ 1.5×ULN, or creatinine clearance rate ≥ 50 mL/min;
- If HBV-DNA ≥ 10^4 copies/mL (2000 IU/mL), antiviral and liver protection therapy must be used before enrollment, until HBV-DNA < 10^4 copies/mL (2000 IU/mL). In which case, the antiviral drugs should be administered continuously and liver function and hepatitis B virus load will be monitored during the study period;
- Patients who meet one of two conditions: (A) are not or less appropriate candidates for first-line standard treatments recommended by the guidelines; (B) are not willing to receive first-line standard treatments recommended by the guidelines.
- Surgical resection ended > 3 months, local ablation, hepatic artery intervention or radiotherapy ended > 4 weeks before randomization (implantation of radioactive particles ended > 3 months) and relevant adverse reactions having recovered. Patients without extrahepatic spread must have radiographic evidence of disease progression after local treatment;
- Patients who had previously received adjuvant systemic therapy after surgical resection experienced the first radiographic disease progression more than 6 months after withdrawal of adjuvant therapy will be eligible for enrollment;
- Within 2 weeks prior to randomization, no treatment with modern Chinese traditional medicine preparations with anti-tumor indications (refer to the 11th inclusion criterion when huaier granule was used as systemic adjuvant therapy), immunomodulators such as interferon-α and thymalfasin, tumor vaccines and cellular immunotherapy;
- No blood transfusion or infusion of blood products, no use of hematopoietic growth factors (such as granulocyte colony-stimulating factor G-CSF), and no albumin infusion within 2 weeks prior to randomization;
- ≥1 measurable lesion according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1), defined as a non-lymphoid lesion with the longest diameter ≥ 10 mm or a lymph node lesion with the short axis ≥ 15 mm; a lesion after previous radiotherapy or other loco-regional therapy which has been demonstrated progression confirmed per RECIST v1.1 with the longest diameter ≥ 10 mm scanned by dynamic-enhanced CT/ dynamic-enhanced MRI is to be deemed as a measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1;
- Expected survival of ≥ 12 weeks;
- Female patients of childbearing age with a negative blood pregnancy within the first 7 days prior to randomization will be eligible; Female patients of childbearing age or male patients with female sexual partners of childbearing age should take effective contraceptive measures throughout treatment and within 3 months after the last dose;
- Voluntary agreement to sign informed consent and the willingness and ability to comply with protocol schedules and testing;
- No treatment with any other investigational drugs or medical devices within 4 weeks prior to randomization.
Who cannot join
- Tumor occupancy ≥ 70% of liver, or tumor thrombus occupancy ≥ 50% of the main trunk of portal vein, or mesenteric vein or inferior vena cava tumor thrombus;
- Moderate-to-severe ascites, i.e., the score of the indicator is > 2; Moderate-to-severe, or symptomatic pleural effusion and pericardial effusion requiring drainage;
- Receipt of major surgery (craniotomy, thoracotomy, laparotomy, hip replacement, etc.) within 28 days prior to randomization or planned to receive major surgery during the study;
- Other types of primary liver cancer, such as intrahepatic cholangiocarcinoma, mixed HCC and cholangiocarcinoma, fibrolamellar HCC, etc. Other malignancies within 5 years prior to signing the informed consent form or at present, excluding radically treated basal cell carcinoma of skin, squamous cell carcinoma of skin and/or radically resected carcinoma in situ;
- Pregnant or lactating women;
- Grade 2 or above myocardial ischemia or myocardial infarction (NCI-CTCAE v5.0), poorly-controlled arrhythmia, and/or New York Heart Association (NYHA) class III or IV cardiac insufficiency;
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- Patients who previously received allogeneic transplantation including liver transplantation, or plan to undergo liver transplantation during the study;
- History of hepatic encephalopathy and/or hepatic nephropathy within 6 months prior to signing informed consent ;
- HCV-RNA positive, ALT and/or AST > 2×ULN;
- Human immunodeficiency virus (HIV) antibody positive;
- Severe infection (≥ Grade 3 of NCI-CTCAE v5.0 criteria) at randomization;
- Unable to swallow, chronic diarrhea or intestinal obstruction, which will significantly affect oral administration and absorption of the study drug;
- History of gastrointestinal hemorrhage within 6 months before signing informed consent, or with clear tendency for gastrointestinal hemorrhage at present, such as: local active ulcers, stool occult blood ≥ 2+ or positive at two consecutive tests (attention should be paid to exclude the influence of food, drugs and other diseases);
- Active autoimmune diseases requiring systemic treatment (e.g., NSAIDs, immunosuppressants, biologics, corticosteroids, etc.) except for patients receiving replacement therapy (e.g., hypothyroidism treated with thyroxine, type 1 diabetes mellitus treated with insulin, adrenal or pituitary insufficiency treated with physiologic corticosteroids, etc.);
- Known central nervous system (CNS) metastasis; patients suspected of CNS metastasis need to undergo cerebral MRI/CT for exclusion;
- Significant coagulation function abnormalities: international standardized ratio (INR) > 1.5 or prothrombin time (PT) > 16 s;
- History of schizophrenia or psychiatric drug abuse;
- Known allergy or intolerance to any ingredients of icaritin or huachansu preparations;
- Other conditions that the investigator considers inappropriate for participation in this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Chifeng Municipal Hospital
Chifeng, Mongolia
Hongbo Ji, Doctor, 0476-8231279, 2060255120@qq.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
JianBin Wu, Doctor, 0791-86300985, 585482997@qq.com
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao, MD, 022-23340123, haojihui@tjmuch.com
About this study
Official title: A Prospective, Randomized, Parallel-Controlled, Double-Blind, Double-Dummy, Multicenter, Phase III Clinical Trial of Icaritin Soft Capsule Versus Huachansu Tablet in the First-line Treatment of Unresectable Hepatocellular Carcinoma With Poor Conditions and Biomarker Enrichment (Biomarker Enrichment Study of Poor Prognosis HCC Patients, BESTPOP)
A study to evaluate the efficacy and safety of icaritin versus huachansu in the first-line treatment of unresectable hepatocellular carcinoma with poor conditions and biomarker enrichment.
Read the detailed description
This is a prospective, randomized, parallel-controlled, double-blind, double-dummy, multicenter, phase III clinical trial. Patients with poor conditions and biomarker enrichment will be randomly assigned in a 2:1 ratio to receive either icaritin or huachansu as the first-line treatment until unacceptable toxic effects and loss of clinical benefit. A total of 261 participants with 206 deaths are required. The primary endpoint is overall survival (OS) in the full analysis set (FAS) population.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Icaritin, Huachansu
- Keywords
- Icaritin, Poor Conditions, Composite Biomarker, First-line Treatment
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcaritinDrug
600 mg (6 x 100 mg capsules) icaritin administered orally twice daily (30 minutes after breakfast and dinner, respectively) until treatment discontinuation criteria are met.
HuachansuDrug
1200 mg (4 x 300 mg tablets) huachansu administered orally three times a day (30 minutes after breakfast, lunch and dinner, respectively) until treatment discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Icaritin soft capsule | Experimental | Not described Receives: Drug: Icaritin |
| Huachansu tablet | Active comparator | Not described Receives: Drug: Huachansu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Defined as the time from randomization to death from any cause
Measured: From randomization to death from any cause, assessed up to approximately 24 months
Secondary outcomes (10)
9/12/18-month overall survival (OS) rate
Defined as the percentage of participants who are alive at 9, 12, 18 months following randomization
Measured: From randomization to 9, 12 and 18 months later
Time to progression (TTP)
Defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator and IRC according to RECIST v1.1
Measured: From randomization to the first occurrence of disease progression, assessed up to approximately 24 months
Progression--free survival (PFS)
Defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator and IRC according to RECIST v1.1
Measured: From randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), assessed up to approximately 24 months
Objective response rate (ORR)
Defined as the percentage of participants with complete response (CR) or partial response (PR), as determined by the investigator and IRC according to RECIST v1.1
Measured: Up to approximately 24 months after randomization
Disease control rate (DCR)
Defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD), as determined by the investigator and IRC according to RECIST v1.1
Measured: Up to approximately 24 months after randomization
Time to deterioration (TTD)
Defined as the time from randomization to first deterioration, i.e., decrease or increase from baseline of ≥ 10 points in the following EORTC QLQ-C30 and EORTC QLQ-HCC18 subscales respectively, maintained for two consecutive assessments or one assessment followed by death from any cause within 4 weeks:
Measured: From randomization to first deterioration, assessed up to approximately 24 months
Adverse events (AEs)
Defined as all untoward medical events in a participant administered the study drug, which can be symptoms, signs, diseases or laboratory abnormalities, irrespective of the causality with the study drug.
The type, incidence, severity, and relationship with study drugs of adverse events (AEs) will be evaluated.
Measured: Up to approximately 24 months after randomization
Trough plasma concentration (Cmin）
Defined as trough plasma concentration（Cmin）of icaritin and its metabolites
Measured: Pre-dose at the end of cycle1 (Cycle length=28 days)
Maximum plasma concentration (Cmax)
Defined as maximum plasma concentration (Cmax) of icaritin and its metabolites
Measured: Post-dose at the end of cycle1 (Cycle length=28 days)
Mean area under the concentration-time curve during the dosing interval (AUC0-t)
Defined as Mean area under the concentration-time curve during the dosing interval (AUC0-t) of icaritin and its metabolites at steady state
Measured: Within 0.5 h before dosing (0 h) and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, and 12 h after dosing at the end of cycle1 (Cycle length=28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start12 Dec 2022
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 261 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Shenogen Biomedical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihui Hao, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594927
- Sponsor's protocol ID
- SNG2111-ICR-1
- Acronym
- BESTPOP
- Status last verified
- Aug 2024
- First submitted
- 17 Oct 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel-Controlled, Double-Blind, Double-Dummy, Multicenter, Phase III Clinical Trial of Icaritin Soft Capsule Versus Huachansu Tablet in the First-line Treatment of Unresectable Hepatocellular Carcinoma With Poor Conditions and Biomarker Enrichment (Biomarker Enrichment Study of Poor Prognosis HCC Patients, BESTPOP)
- ClinicalTrials.gov ID
- NCT05594927
- Acronym / sponsor ID
- BESTPOP / SNG2111-ICR-1
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Icaritin, Poor Conditions, Composite Biomarker, First-line Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 261 participants (estimated)
- Lead sponsor
- Beijing Shenogen Biomedical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 26 Oct 2022 (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.
A study to evaluate the efficacy and safety of icaritin versus huachansu in the first-line treatment of unresectable hepatocellular carcinoma with poor conditions and biomarker enrichment.
Detailed description
This is a prospective, randomized, parallel-controlled, double-blind, double-dummy, multicenter, phase III clinical trial. Patients with poor conditions and biomarker enrichment will be randomly assigned in a 2:1 ratio to receive either icaritin or huachansu as the first-line treatment until unacceptable toxic effects and loss of clinical benefit. A total of 261 participants with 206 deaths are required. The primary endpoint is overall survival (OS) in the full analysis set (FAS) population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icaritin soft capsule | Experimental | Drug: Icaritin |
| Huachansu tablet | Active comparator | Drug: Huachansu |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female, 18 years and older;
- HCC patients who meet the clinical diagnostic criteria of the Chinese Diagnosis and Treatment Guideline of Primary Liver Cancer (2022 edition), and/or with diagnosis confirmed histopathologically/cytologically;
- Unresectable HCC patients;
- Patients with a peripheral blood composite biomarker Score ≥ 2 points, 1 point each for AFP ≥ 400 ng/mL, TNF-α < 2.5 pg/mL, and IFN-γ ≥ 7.0 pg/mL ;
- No prior first-line systemic treatment for HCC, including sorafenib, lenvatinib, donafenib, atezolizumab plus bevacizumab, sintilimab plus a bevacizumab biosimilar, camrelizumab plus apatinib, and durvalumab plus tremelimumab, oxaliplatin-based systemic chemotherapy (FOLFOX4) , icaritin, huachansu, and other anti-cancer drugs such as targeted agents, immune checkpoint inhibitors, and systemic chemotherapy;
Key exclusion criteria (19 listed)
- Tumor occupancy ≥ 70% of liver, or tumor thrombus occupancy ≥ 50% of the main trunk of portal vein, or mesenteric vein or inferior vena cava tumor thrombus;
- Moderate-to-severe ascites, i.e., the score of the indicator is > 2; Moderate-to-severe, or symptomatic pleural effusion and pericardial effusion requiring drainage;
- Receipt of major surgery (craniotomy, thoracotomy, laparotomy, hip replacement, etc.) within 28 days prior to randomization or planned to receive major surgery during the study;
- Other types of primary liver cancer, such as intrahepatic cholangiocarcinoma, mixed HCC and cholangiocarcinoma, fibrolamellar HCC, etc. Other malignancies within 5 years prior to signing the informed consent form or at present, excluding radically treated basal cell carcinoma of skin, squamous cell carcinoma of skin and/or radically resected carcinoma in situ;
- Pregnant or lactating women;
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 |
|---|---|---|
| Icaritin600 mg (6 x 100 mg capsules) icaritin administered orally twice daily (30 minutes after breakfast and dinner, respectively) until treatment discontinuation criteria are met. | Drug | Icaritin soft capsule |
| Huachansu1200 mg (4 x 300 mg tablets) huachansu administered orally three times a day (30 minutes after breakfast, lunch and dinner, respectively) until treatment discontinuation criteria are met. | Drug | Huachansu tablet |
Primary outcome
Overall survival (OS)
Time frame: From randomization to death from any cause, assessed up to approximately 24 months
Defined as the time from randomization to death from any cause
10 secondary outcomes
9/12/18-month overall survival (OS) rate
Time frame: From randomization to 9, 12 and 18 months later
Time to progression (TTP)
Time frame: From randomization to the first occurrence of disease progression, assessed up to approximately 24 months
Progression--free survival (PFS)
Time frame: From randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), assessed up to approximately 24 months
Objective response rate (ORR)
Time frame: Up to approximately 24 months after randomization
Disease control rate (DCR)
Time frame: Up to approximately 24 months after randomization
Time to deterioration (TTD)
Time frame: From randomization to first deterioration, assessed up to approximately 24 months
Adverse events (AEs)
Time frame: Up to approximately 24 months after randomization
Trough plasma concentration (Cmin）
Time frame: Pre-dose at the end of cycle1 (Cycle length=28 days)
Maximum plasma concentration (Cmax)
Time frame: Post-dose at the end of cycle1 (Cycle length=28 days)
Mean area under the concentration-time curve during the dosing interval (AUC0-t)
Time frame: Within 0.5 h before dosing (0 h) and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, and 12 h after dosing at the end of cycle1 (Cycle length=28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Jihui Hao, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Icaritin and Huachansu in people with Hepatocellular Carcinoma, run by Beijing Shenogen Biomedical Co., Ltd at 3 sites 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 22 inclusion and 19 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jihui Hao, MD (022-23340123, haojihui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From randomization to death from any cause, assessed up to approximately 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 7 Aug 2024.