Unresectable Hepatocellular CarcinomaNCT05660213
A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer
An observational study of Unresectable Hepatocellular Carcinoma, run by Fudan University.
Trial summary
This study is a multicenter, registered research aimed at evaluating the efficacy of different treatment regimens in the treatment of unresectable CNLC liver cancer stage III hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- Targeted drugs combined with anti-PD-1/PD-L1 antibodies, TACE (transarterial chemoembolization) combined with targeted/immunotherapy and Lenvatinib monotherapy
- Type of treatment
- Pill or oral medicine
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 2030
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During the whole study period, a total of 750 patients in the selected research centers from December 2024 to December 2025 were planned to be recruited consecutively, including 150 in cohort a, 150 in cohort B, 150 in cohort C, and 300 in cohort D. A single subject was visited every 8 weeks after enrollment until the diagnosis and treatment mode changed, disease progression or the patient withdrew from the study or died for any reason, whichever occurred first. The maximum duration of a single subject's total visit shall not exceed 24 months.
Who may be able to join
- ·≥ 18 years old;
- Diagnosed as unresectable hepatocellular carcinoma through histopathological and/or cytological examination, or meeting the clinical diagnostic criteria for hepatocellular carcinoma in the 2022 edition of the guidelines for the diagnosis and treatment of primary liver cancer;
- CNLC liver cancer stage III;
- Liver function Child Pugh A or B grade 7 points;
- Has not received systematic treatment in the past;
- Patients with active HBV infection who meet one of the following conditions can be enrolled: ① Within 28 days before enrollment, the patient's HBV DNA is less than 500 IU/mL. If they have received anti HBV treatment, they need to continue their original antiviral treatment; If anti HBV treatment has not been received, it is necessary to receive anti HBV treatment throughout the entire course of medication (according to local treatment standards; for example, entecavir); ② For patients with HBV DNA>500 IU/mL and who have not received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Before enrollment, the serum HBV-DNA virus should be retested to decrease by more than 1 log value For patients with HBV DNA>500 IU/mL and who have received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Serum HBV-DNA virus levels should be retested before enrollment;
Show all 10Show fewer
- Active HCV infected individuals with stable disease status after treatment;
- At least one tumor lesion available for evaluation;
- Clear consciousness, language expression ability or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation;
- Voluntarily join this study and sign an informed consent form.
Who cannot join
- Simultaneously having two or more active primary malignant tumors;
- Portal vein cancer thrombus invades the superior mesenteric vein;
- Received radiation therapy within the past 4 weeks;
- Expected survival time is less than 3 months;
- Pregnant or lactating women or those planning to conceive;
- Coagulation dysfunction (INR>2.0, PT>16 s) or diseases with a strong likelihood of bleeding (including but not limited to esophageal and/or gastric variceal bleeding, active ulcers, uncontrolled hypertension);
- Refusing to cooperate with follow-up visits;
- Other reasons led the researchers to believe that it was not suitable to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Registry Study on the Efficacy and Safety of Different Treatment Regimens for Unresectable CNLC Liver Cancer Stage III Hepatocellular Carcinoma
This study is a multicenter, registered research aimed at evaluating the efficacy of different treatment regimens in the treatment of unresectable CNLC liver cancer stage III hepatocellular carcinoma
Read the detailed description
This study is a multicenter, observational, natural cohort registration study. We plan to continuously include 750 subjects diagnosed with unresectable CNLC stage III hepatocellular carcinoma (HCC) at selected research centers. According to the actual clinical diagnosis and treatment plan of patients, the following treatment modes will be included in the Cohort of patients:
Cohort A: Targeted drugs combined with anti-PD-1/PD-L1 antibodies Cohort B: TACE (transarterial chemoembolization) combined with targeted/immunotherapy Cohort C: Lenvatinib monotherapy Cohort D: Huaier granules combined with any of the above Cohorts for treatment Throughout the entire study period, it is planned to recruit patients who have visited the selected research center within 12 months (December 2024 to December 2025). Each individual subject will be followed up every 8 weeks until the diagnosis and treatment mode changes, disease progression progresses, or the patient withdraws from the study or dies for any reason, whichever occurs first.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Targeted drugs combined with anti-PD-1/PD-L1 antibodies, TACE (transarterial chemoembolization) combined with targeted/immunotherapy, Lenvatinib monotherapy, Huaier granules combined with any of the above Cohorts for treatment
- Keywords
- Huaier granules, Unresectable hepatocellular carcinoma, curative effect, safety, Anti-PD-1/PD-L1 antibody drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted drugs combined with anti-PD-1/PD-L1 antibodiesDrug
Targeted drugs combined with anti-PD-1/PD-L1 antibodies
TACE (transarterial chemoembolization) combined with targeted/immunotherapyDrug
TACE (transarterial chemoembolization) combined with targeted/immunotherapy
Lenvatinib monotherapyDrug
For patients weighing less than 60 kg, the recommended daily dose of this product is 8 mg (2 capsules of 4 mg), once daily; For patients weighing ≥ 60 kg, the recommended daily dose of this product is 12 mg (3 capsules of 4 mg), once daily. Treatment should be continued until disease progression or intolerable toxic reactions occur.
Huaier granules combined with any of the above Cohorts for treatmentDrug
Also called Z20000109#NMPA Approval Number#
Oral administration of Huaier granules, 10g each time, 3 times a day, until the end of the study, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that there is no longer any benefit.It is recommended that the date of first use of Huaier granules be determined by the researchers, and after disease progression, the researchers and patients should jointly decide whether to continue receiving Huaier granules treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Targeted drugs combined with anti-PD-1 / PD-L1 antibodies Receives: Drug: Targeted drugs combined with anti-PD-1/PD-L1 antibodies | |
| Cohort B | TACE (transarterial chemoembolization) combined with target immunotherapy Receives: Drug: TACE (transarterial chemoembolization) combined with targeted/immunotherapy | |
| Cohort C | Lenvatinib monotherapy Receives: Drug: Lenvatinib monotherapy | |
| Cohort D | Huaier granules combined with any of the above Cohorts for treatment Receives: Drug: Huaier granules combined with any of the above Cohorts for treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORRObjective response rate (ORR)
It defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) in primary tumor imaging evaluation.
Measured: start of treatment until 24-month follow-up
Progression free survival (PFS)
It defined as the time from the date the subject first receives combination therapy until the first observation of tumor progression or death from any cause.
Measured: Start of treatment until 24-month follow-up
Disease control rate (DCR)
It defined as the proportion of subjects who achieve complete response (CR), partial response (PR), or disease stability (SD) as assessed by primary tumor imaging.
Measured: Start of treatment until 24-month follow-up
Time to Response（TTR）
It defined as the time from the date the subject first receives combination therapy to the first observation of tumor response (CR or PR).
Measured: Start of treatment until 24-month follow-up
Duration of Response (DoR)
It defined as the time from the first observation of tumor remission (CR or PR) in a subject receiving combination therapy to the first observation of tumor progression or death from any cause.
Measured: Start of treatment until 24-month follow-up
Overall survival (OS):
It defined as the time from the day of randomization of patients to death from any cause.
Measured: Start of treatment until 24-month follow-up
Secondary outcomes (4)
Quality of Life Score
Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.
Measured: Start of treatment until 24-month follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
The definition and severity grading of AE and SAE refer to the corresponding descriptions in the definition and evaluation section of adverse events, and the incidence rate is defined as the proportion of patients with AE and SAE to the corresponding total population.
Measured: Start of treatment until 24-month follow-up
The incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)
The definition and severity grading of ADR, severe ADR, and SUSAR refer to the corresponding descriptions in the definition and evaluation section of adverse events. The incidence rate is defined as the proportion of patients with ADR, severe ADR, and SUSAR to the corresponding total population.
Measured: Start of treatment until 24-month follow-up
The incidence and severity of Adverse Events of Special Concern (AESI)
AESI includes proteinuria, enteritis, and immune-mediated myocarditis. The incidence is defined as the proportion of patients who experience AESI to the corresponding total population, and the severity grading refers to the corresponding description in the definition and evaluation section of adverse events.
Measured: Start of treatment until 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study startAug 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2030 (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.
- More trials run by Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Jia Fan, Fudan University
- Investigators
- Jia Fan, PhD, Principal investigator, Affiliated Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660213
- Sponsor's protocol ID
- HELICOP
- Status last verified
- May 2025
- First submitted
- 13 Dec 2022
- Last updated
- 20 May 2025
- 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 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry Study on the Efficacy and Safety of Different Treatment Regimens for Unresectable CNLC Liver Cancer Stage III Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05660213
- Acronym / sponsor ID
- HELICOP
- Conditions
- Unresectable Hepatocellular Carcinoma
- Keywords
- Huaier granules, Unresectable hepatocellular carcinoma, curative effect, safety, Anti-PD-1/PD-L1 antibody drugs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 21 Dec 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.
This study is a multicenter, registered research aimed at evaluating the efficacy of different treatment regimens in the treatment of unresectable CNLC liver cancer stage III hepatocellular carcinoma
Detailed description
This study is a multicenter, observational, natural cohort registration study. We plan to continuously include 750 subjects diagnosed with unresectable CNLC stage III hepatocellular carcinoma (HCC) at selected research centers. According to the actual clinical diagnosis and treatment plan of patients, the following treatment modes will be included in the Cohort of patients:
Cohort A: Targeted drugs combined with anti-PD-1/PD-L1 antibodies Cohort B: TACE (transarterial chemoembolization) combined with targeted/immunotherapy Cohort C: Lenvatinib monotherapy Cohort D: Huaier granules combined with any of the above Cohorts for treatment Throughout the entire study period, it is planned to recruit patients who have visited the selected research center within 12 months (December 2024 to December 2025). Each individual subject will be followed up every 8 weeks until the diagnosis and treatment mode changes, disease progression progresses, or the patient withdraws from the study or dies for any reason, whichever occurs first.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: Targeted drugs combined with anti-PD-1/PD-L1 antibodiesTargeted drugs combined with anti-PD-1 / PD-L1 antibodies |
| Cohort B | – | Drug: TACE (transarterial chemoembolization) combined with targeted/immunotherapyTACE (transarterial chemoembolization) combined with target immunotherapy |
| Cohort C | – | Drug: Lenvatinib monotherapyLenvatinib monotherapy |
| Cohort D | – | Drug: Huaier granules combined with any of the above Cohorts for treatmentHuaier granules combined with any of the above Cohorts for treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During the whole study period, a total of 750 patients in the selected research centers from December 2024 to December 2025 were planned to be recruited consecutively, including 150 in cohort a, 150 in cohort B, 150 in cohort C, and 300 in cohort D. A single subject was visited every 8 weeks after enrollment until the diagnosis and treatment mode changed, disease progression or the patient withdrew from the study or died for any reason, whichever occurred first. The maximum duration of a single subject's total visit shall not exceed 24 months.
Key inclusion criteria (10 listed)
- ·≥ 18 years old;
- Diagnosed as unresectable hepatocellular carcinoma through histopathological and/or cytological examination, or meeting the clinical diagnostic criteria for hepatocellular carcinoma in the 2022 edition of the guidelines for the diagnosis and treatment of primary liver cancer;
- CNLC liver cancer stage III;
- Liver function Child Pugh A or B grade 7 points;
- Has not received systematic treatment in the past;
Key exclusion criteria (8 listed)
- Simultaneously having two or more active primary malignant tumors;
- Portal vein cancer thrombus invades the superior mesenteric vein;
- Received radiation therapy within the past 4 weeks;
- Expected survival time is less than 3 months;
- Pregnant or lactating women or those planning to conceive;
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 |
|---|---|---|
| Targeted drugs combined with anti-PD-1/PD-L1 antibodiesTargeted drugs combined with anti-PD-1/PD-L1 antibodies | Drug | Cohort A |
| TACE (transarterial chemoembolization) combined with targeted/immunotherapyTACE (transarterial chemoembolization) combined with targeted/immunotherapy | Drug | Cohort B |
| Lenvatinib monotherapyFor patients weighing less than 60 kg, the recommended daily dose of this product is 8 mg (2 capsules of 4 mg), once daily; For patients weighing ≥ 60 kg, the recommended daily dose of this product is 12 mg (3 capsules of 4 mg), once daily. Treatment should be continued until disease progression or intolerable toxic reactions occur. | Drug | Cohort C |
| Huaier granules combined with any of the above Cohorts for treatmentAlso: Z20000109#NMPA Approval Number#Oral administration of Huaier granules, 10g each time, 3 times a day, until the end of the study, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that there is no longer any benefit.It is recommended that the date of first use of Huaier granules be determined by the researchers, and after disease progression, the researchers and patients should jointly decide whether to continue receiving Huaier granules treatment. | Drug | Cohort D |
Primary outcome
ORRObjective response rate (ORR)
Time frame: start of treatment until 24-month follow-up
It defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) in primary tumor imaging evaluation.
Progression free survival (PFS)
Time frame: Start of treatment until 24-month follow-up
It defined as the time from the date the subject first receives combination therapy until the first observation of tumor progression or death from any cause.
Disease control rate (DCR)
Time frame: Start of treatment until 24-month follow-up
It defined as the proportion of subjects who achieve complete response (CR), partial response (PR), or disease stability (SD) as assessed by primary tumor imaging.
Time to Response（TTR）
Time frame: Start of treatment until 24-month follow-up
It defined as the time from the date the subject first receives combination therapy to the first observation of tumor response (CR or PR).
Duration of Response (DoR)
Time frame: Start of treatment until 24-month follow-up
It defined as the time from the first observation of tumor remission (CR or PR) in a subject receiving combination therapy to the first observation of tumor progression or death from any cause.
Overall survival (OS):
Time frame: Start of treatment until 24-month follow-up
It defined as the time from the day of randomization of patients to death from any cause.
4 secondary outcomes
Quality of Life Score
Time frame: Start of treatment until 24-month follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
Time frame: Start of treatment until 24-month follow-up
The incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)
Time frame: Start of treatment until 24-month follow-up
The incidence and severity of Adverse Events of Special Concern (AESI)
Time frame: Start of treatment until 24-month follow-up
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 20 May 2025.
- Individual participant dataSharing planned: No
Related trials for Unresectable Hepatocellular Carcinoma
Not yet recruitingPhase 2
PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC
Hepatocellular Carcinoma
Active, not recruitingPhase 3
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7
Active, not recruitingPhase 1/2
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
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.
Jia Fan, PhD principal investigator
Affiliated Zhongshan Hospital, Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Hepatocellular Carcinoma, run by Fudan University.
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 10 inclusion and 8 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 20 May 2025. 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.
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 Jia Fan, PhD (+86 021-64041990, Fan.jia@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORRObjective response rate (ORR) (time frame: start of treatment until 24-month follow-up). The study lists 6 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 20 May 2025.