Hepatocellular Carcinoma(HCC)ICT-HCCNCT06893887
Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma
A study testing FOLFOX4, Adebrelimab and Apatinib in people with Hepatocellular Carcinoma(HCC), run by Nanjing Tianyinshan Hospital at 1 site in China.
Trial summary
This project is a prospective, multi-center, multi-cohort exploratory clinical study. It focuses on patients with advanced hepatocellular carcinoma who experience disease progression after first-line standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma(HCC)
- What is being tested?
- FOLFOX4, Adebrelimab and Apatinib
- 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
- 270 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2025to 15 Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years old, male or female
- Hepatocellular carcinoma patients diagnosed by cytology or tissue puncture, or who meet clinical diagnostic criteria and cannot be treated with radical treatment (radical surgery, ablation, radiotherapy, etc.)
- Clinical disease progression after first-line targeted combined immune system therapy (PD-1 or PD-L1 monoclonal antibody only)
- Life expectancy exceeds 3 months
- ECOG physical condition score 0~1
- Women of childbearing age must have a serum pregnancy study done within 7 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must consent to contraception within 24 weeks from the date of signing the informed consent to the last administration of the study drug
- Before the first dose of the investigational drug, the laboratory test values met the following conditions: ①blood routine (no blood transfusion within 14 days before screening, no hematopoietic stimulating drug correction) : white blood cell count (WBC) ≥ 2.0 × 109/L; platelet (PLT) ≥ 60× 109/L; hemoglobin content (HGB) ≥ 8.0 g/dL; ② Liver function: aspartate transferase (AST) ≤ 2.5x ULN; alanine aminotransferase (ALT) ≤ 2.5 x ULN; Serum total bilirubin (TBIL) ≤ 1.5 x ULN (except Gilbert syndrome total bilirubin ≤ 3.0 mg/dL); ③ Renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CrCl) ≥ 50 mL/minute; ④ Coagulation function: international normalized ratio (INR) ≤ 1.5 x ULN, activated partial thromboplastin time (APTT) ≤ 1.5 x ULN (only for patients who are not currently receiving anticoagulant therapy, patients who are currently receiving anticoagulant therapy should receive a steady dose of anticoagulant therapy)
- The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up
Who cannot join
- Pathological types of other non-hepatocellular carcinomas, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. previously confirmed by histology/cytology
- Child-Pugh grade of liver function> 7 points
- Major cardiovascular impairment in the 6 months prior to initial administration of the drug, such as a New York Heart Association (NYHA) Class II or higher history of congestive heart failure, unstable angina, myocardial infarction or stroke, or arrhythmia associated with hemodynamic instability; Corrected QT (QTc) interval lengthening >480ms
- Other malignancies developed ≤ 5 years before the first dose, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed)
- Have had an active autoimmune disease in the past 2 years that requires systemic treatment, including but not limited to autoimmune hepatitis, lupus erythematosus, etc
- Uncontrolled active infection, such as active tuberculosis, HIV infection, etc.; Patients with HBV-DNA replication level below 10000IU/mL and continuous oral antiviral therapy could be enrolled.
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- Had undergone major surgery in the 28 days prior to randomization or planned to undergo major surgery during the study period
- Use of live attenuated vaccine within 28 days prior to randomization, or anticipated use of such live attenuated vaccine during the study period (patients are not allowed to receive live attenuated influenza vaccine 4 weeks prior to randomization, during treatment, and within 5 months after the final administration of adbelizumab)
- Received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the ICF
- Use of corticosteroids (> 10 mg/ day prednisone or equivalent dose) or other immunosuppressants within ≤ 14 days prior to the first dose of the study drug. Allowing inhaled or topical use of steroids and adrenal replacement steroids in the absence of active autoimmune disease; Patients received systemic immunosuppressive drugs (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] drugs) within 1 week prior to randomization. Patients receiving short-term, systemic immunosuppressant therapy, such as glucocorticoids for nausea, vomiting, or anaphylaxis management or prevention, may be enrolled in the study after investigator review. To allow the use of inhaled corticosteroids in patients with chronic obstructive pulmonary disease, corticosteroids such as fluhydrocortisone in patients with postural hypotension, and low-dose glucocorticoid supplements for adrenal insufficiency; Known mental illness, alcoholism, inability to quit smoking, drug or substance abuse
- In the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as non-compliance with the protocol, other serious illnesses (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors that may affect the safety of the subjects, or the collection of data and samples
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, 1 recruiting
- Recruiting
China Pharmaceutical University Affiliated Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, 210000
Chen Xun, +86-13851670770, mxrlwx19911990@163.com
About this study
Official title: Exploratory Cohort Study and Mechanistic Research on Individualized Comprehensive Treatment After Standard Treatment for Advanced Hepatocellular Carcinoma
This project is a prospective, multi-center, multi-cohort exploratory clinical study. It focuses on patients with advanced hepatocellular carcinoma who experience disease progression after first-line standard therapy. Based on different patterns of disease progression, patients will receive relevant systemic treatments, either with or without local interventional therapy. The primary endpoint is progression-free survival (PFS), while secondary endpoints include overall survival (OS), 1-year OS rate, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and safety. Additionally, the study will explore the correlation between patients' clinical pathological characteristics, serum biomarkers, and clinical efficacy.
- Conditions
- Hepatocellular Carcinoma(HCC)
- Being tested
- FOLFOX4, Adebrelimab, Apatinib, Icaritin, Retlirafusp alfa
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX4Drug
FOLFOX4 was administered by oxaliplatin 85 mg/m² d1+ leucovorin 200 mg/m² d1-2+ fluorouracil 400 mg/m² 2 h→ 600 mg/m² 24 h d1-2 q2w, with a total of 4 cycles
AdebrelimabDrug
Adebrelimab 1200mg, intravenous infusion, every 3 weeks
ApatinibDrug
Apatinib 250mg, oral, once daily.
IcaritinDrug
Epimedium extract soft capsules 2.4g, oral, 2 times daily.
Retlirafusp alfaDrug
Retlirafusp alfa，1800mg, intravenous infusion, every 3 weeks, use for up to 2 years at most.
QL1706Drug
QL1706，5mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most.
BevacizumabDrug
Bevacizumab 7.5mg, intravenous infusion, once every 3 weeks.
HAICProcedure or surgery
Hepatic Arterial Infusion Chemotherapy
The original treatment regimenDrug
Continue the original targeted therapy combined with immunotherapy. dosage, dosage form,frequency of administration was the same as before.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | XELOX/FOLFOX4+ Adebelizumab + Apatinib+Icaritin Receives: Drug: FOLFOX4; Drug: Adebrelimab |
| Arm 2 | Experimental | Adebelizumab + Apatinib+Icaritin Receives: Drug: Adebrelimab; Drug: Apatinib; Drug: Icaritin |
| Arm 3a | Experimental | QL1706+ Apatinib+Icaritin Receives: Drug: Apatinib; Drug: Icaritin; Drug: QL1706 |
| Arm 3b | Experimental | Retlirafusp alfa+ Apatinib+Icaritin Receives: Drug: Apatinib; Drug: Icaritin; Drug: Retlirafusp alfa |
| Arm 4 | Experimental | The original targeted combination immunotherapy+HAIC Receives: Drug: Apatinib; Drug: Icaritin; Drug: QL1706; Procedure: HAIC; Drug: The original treatment regimen |
| Arm 5a | Experimental | QL1706+ Apatinib+Icaritin Receives: Drug: Apatinib; Drug: Icaritin; Drug: QL1706 |
| Arm 5b | Experimental | Retlirafusp alfa+ Apatinib+Icaritin Receives: Drug: Apatinib; Drug: Icaritin; Drug: Retlirafusp alfa |
| Arm 6a | Experimental | QL1706+Bevacizumab+Icaritin Receives: Drug: Icaritin; Drug: QL1706; Drug: Bevacizumab |
| Arm 6b | Experimental | Retlirafusp alfa+Bevacizumab+Icaritin Receives: Drug: Icaritin; Drug: Retlirafusp alfa; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS（Progression-free Survival）
Progression-free survival (PFS) was defined as the time from treatment initiation on Day 1 to the earliest occurrence of radiologically confirmed disease progression, as assessed by tumor imaging, or death from any cause, whichever came first. Evaluations were conducted by the investigator in accordance with RECIST v1.1.
Measured: 24 months
Secondary outcomes (4)
OS(Overall survival)
Overall survival (OS) was defined as the duration from treatment initiation on Day 1 to death from any cause.
Measured: 48 months
ORR(Objective response rate)
Objective response rate (ORR) was defined as the proportion of subjects achieving a complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST v1.1, from the initiation of treatment on Day 1.
Measured: 24 months
DCR(Disease control rate )
Disease control rate (DCR) was defined as the proportion of subjects achieving a complete response (CR), partial response (PR), or stable disease (SD) lasting ≥8 weeks, as assessed by the investigator according to RECIST v1.1, from the initiation of treatment on Day 1.
Measured: 24 months
DOR(Duration of Response)
Duration of response (DOR) was defined as the time from the first documented objective response (CR or PR) to the earliest occurrence of radiological disease progression or death from any cause, whichever occurred first. Both response and progression were evaluated by the investigator according to RECIST v1.1.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start22 May 2025
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma(HCC)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Tianyinshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893887
- Sponsor's protocol ID
- E2025-KT-005-01
- Acronym
- ICT-HCC
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 1 Oct 2026
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Cohort Study and Mechanistic Research on Individualized Comprehensive Treatment After Standard Treatment for Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06893887
- Acronym / sponsor ID
- ICT-HCC / E2025-KT-005-01
- Conditions
- Hepatocellular Carcinoma(HCC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Nanjing Tianyinshan HospitalUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 25 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.
This project is a prospective, multi-center, multi-cohort exploratory clinical study. It focuses on patients with advanced hepatocellular carcinoma who experience disease progression after first-line standard therapy. Based on different patterns of disease progression, patients will receive relevant systemic treatments, either with or without local interventional therapy. The primary endpoint is progression-free survival (PFS), while secondary endpoints include overall survival (OS), 1-year OS rate, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and safety. Additionally, the study will explore the correlation between patients' clinical pathological characteristics, serum biomarkers, and clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: FOLFOX4, Drug: AdebrelimabXELOX/FOLFOX4+ Adebelizumab + Apatinib+Icaritin |
| Arm 2 | Experimental | Drug: Adebrelimab, Drug: Apatinib, Drug: IcaritinAdebelizumab + Apatinib+Icaritin |
| Arm 3a | Experimental | Drug: Apatinib, Drug: Icaritin, Drug: QL1706QL1706+ Apatinib+Icaritin |
| Arm 3b | Experimental | Drug: Apatinib, Drug: Icaritin, Drug: Retlirafusp alfaRetlirafusp alfa+ Apatinib+Icaritin |
| Arm 4 | Experimental | Drug: Apatinib, Drug: Icaritin, Drug: QL1706, Procedure: HAIC, Drug: The original treatment regimenThe original targeted combination immunotherapy+HAIC |
| Arm 5a | Experimental | Drug: Apatinib, Drug: Icaritin, Drug: QL1706QL1706+ Apatinib+Icaritin |
| Arm 5b | Experimental | Drug: Apatinib, Drug: Icaritin, Drug: Retlirafusp alfaRetlirafusp alfa+ Apatinib+Icaritin |
| Arm 6a | Experimental | Drug: Icaritin, Drug: QL1706, Drug: BevacizumabQL1706+Bevacizumab+Icaritin |
| Arm 6b | Experimental | Drug: Icaritin, Drug: Retlirafusp alfa, Drug: BevacizumabRetlirafusp alfa+Bevacizumab+Icaritin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old, male or female
- Hepatocellular carcinoma patients diagnosed by cytology or tissue puncture, or who meet clinical diagnostic criteria and cannot be treated with radical treatment (radical surgery, ablation, radiotherapy, etc.)
- Clinical disease progression after first-line targeted combined immune system therapy (PD-1 or PD-L1 monoclonal antibody only)
- Life expectancy exceeds 3 months
- ECOG physical condition score 0~1
Key exclusion criteria (11 listed)
- Pathological types of other non-hepatocellular carcinomas, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. previously confirmed by histology/cytology
- Child-Pugh grade of liver function> 7 points
- Major cardiovascular impairment in the 6 months prior to initial administration of the drug, such as a New York Heart Association (NYHA) Class II or higher history of congestive heart failure, unstable angina, myocardial infarction or stroke, or arrhythmia associated with hemodynamic instability; Corrected QT (QTc) interval lengthening >480ms
- Other malignancies developed ≤ 5 years before the first dose, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed)
- Have had an active autoimmune disease in the past 2 years that requires systemic treatment, including but not limited to autoimmune hepatitis, lupus erythematosus, etc
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 |
|---|---|---|
| FOLFOX4FOLFOX4 was administered by oxaliplatin 85 mg/m² d1+ leucovorin 200 mg/m² d1-2+ fluorouracil 400 mg/m² 2 h→ 600 mg/m² 24 h d1-2 q2w, with a total of 4 cycles | Drug | Arm 1 |
| AdebrelimabAdebrelimab 1200mg, intravenous infusion, every 3 weeks | Drug | Arm 1, Arm 2 |
| ApatinibApatinib 250mg, oral, once daily. | Drug | Arm 2, Arm 3a, Arm 3b, Arm 4, Arm 5a, Arm 5b |
| IcaritinEpimedium extract soft capsules 2.4g, oral, 2 times daily. | Drug | Arm 2, Arm 3a, Arm 3b, Arm 4, Arm 5a, Arm 5b, Arm 6a, Arm 6b |
| Retlirafusp alfaRetlirafusp alfa，1800mg, intravenous infusion, every 3 weeks, use for up to 2 years at most. | Drug | Arm 3b, Arm 5b, Arm 6b |
| QL1706QL1706，5mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most. | Drug | Arm 3a, Arm 4, Arm 5a, Arm 6a |
| BevacizumabBevacizumab 7.5mg, intravenous infusion, once every 3 weeks. | Drug | Arm 6a, Arm 6b |
| HAICHepatic Arterial Infusion Chemotherapy | Procedure or surgery | Arm 4 |
| The original treatment regimenContinue the original targeted therapy combined with immunotherapy. dosage, dosage form,frequency of administration was the same as before. | Drug | Arm 4 |
Primary outcome
PFS（Progression-free Survival）
Time frame: 24 months
Progression-free survival (PFS) was defined as the time from treatment initiation on Day 1 to the earliest occurrence of radiologically confirmed disease progression, as assessed by tumor imaging, or death from any cause, whichever came first. Evaluations were conducted by the investigator in accordance with RECIST v1.1.
4 secondary outcomes
OS(Overall survival)
Time frame: 48 months
ORR(Objective response rate)
Time frame: 24 months
DCR(Disease control rate )
Time frame: 24 months
DOR(Duration of Response)
Time frame: 24 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 1 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOLFOX4, Adebrelimab and Apatinib in people with Hepatocellular Carcinoma(HCC), run by Nanjing Tianyinshan Hospital 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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.
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 Chen Xun (+86-13851670770, mxrlwx19911990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS（Progression-free Survival） (time frame: 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 1 Oct 2026.