Unresectable Hepatocellular Carcinoma (HCC)Phase 2FAD-HCC-001NCT07314372
FAD Subtype-Guided Combination Therapy for Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Camrelizumab Plus Apatinib and TACE Plus Camrelizumab and Apatinib in people with Unresectable Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma (HCC), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This study is a prospective, multicenter Phase II trial evaluating a personalized treatment strategy for patients with unresectable hepatocellular carcinoma (HCC). The study uses a metabolic classification system called the fatty acid degradation (FAD) subtype to guide therapy selection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma (HCC), Liver Cancer Adult
- What is being tested?
- Camrelizumab Plus Apatinib and TACE Plus Camrelizumab and Apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to Dec 2028
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age who voluntarily agree to participate and sign informed consent.
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC).
- Unresectable or not suitable for curative local therapy, or progression after prior surgery or local therapy.
- BCLC stage B or C.
- No prior systemic therapy for HCC.
- At least one measurable lesion according to RECIST v1.1.
Show all 22Show fewer
- Availability of fresh or archival tumor tissue for FAD subtype testing; if not available at screening, MRI fat fraction may be used temporarily.
- Child-Pugh class A or B (≤7 points).
- ECOG performance status 0-1.
- Adequate organ function, including:
- ANC ≥1.5 × 10⁹/L
- Platelets ≥75 × 10⁹/L
- Hemoglobin ≥90 g/L
- Albumin ≥30 g/L
- Total bilirubin ≤1.5 × ULN
- ALT and AST ≤3 × ULN
- Serum creatinine ≤1.5 × ULN or creatinine clearance >50 mL/min
- INR ≤1.2 or PT within 2 seconds above ULN
- Urine protein <2+ or 24-hour urine protein <1.0 g
- Controlled HBV infection (HBV-DNA <2000 IU/mL; if above this level, ≥1 week of antiviral therapy with ≥1-log reduction prior to first dose). HCV-positive individuals must be managed per clinical guidelines.
- Life expectancy ≥12 weeks.
- Women of childbearing potential must have a negative pregnancy test; participants of reproductive potential must agree to effective contraception during treatment and for 6 months afterward.
Who cannot join
- Non-HCC primary liver cancers (e.g., cholangiocarcinoma, combined HCC-CCA).
- F3 subtype without liver lesions on imaging.
- Clinically significant ascites requiring therapeutic intervention, or uncontrolled pleural/pericardial effusion.
- Interstitial lung disease, pneumonitis requiring steroids, or active pulmonary infection.
- Active or history of autoimmune disease requiring systemic treatment (exceptions allowed per protocol, e.g., controlled hypothyroidism).
- Recent use (within 2 weeks) of systemic immunosuppressive therapy >10 mg/day prednisone equivalent.
Show all 18Show fewer
- Gastrointestinal bleeding within 6 months, high-risk varices, active ulcers, fistula, perforation, or intra-abdominal abscess.
- Known bleeding or clotting disorders; therapeutic anticoagulation not permitted.
- Thromboembolic events within 6 months (e.g., stroke, PE).
- Significant cardiovascular disease, including NYHA class ≥II heart failure, recent MI (within 1 year), unstable angina, clinically significant arrhythmias, or QTc prolongation.
- Uncontrolled hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg despite treatment), or history of hypertensive crisis.
- Major vascular disease within 6 months (e.g., arterial thrombosis, aneurysm requiring repair).
- Serious non-healing wounds, active ulcers, or fractures.
- Inability to swallow oral medication or conditions affecting drug absorption.
- Severe infection within 4 weeks, therapeutic antibiotics within 14 days, fever ≥38.5°C within 7 days before enrollment, or WBC >15 × 10⁹/L.
- Known HIV infection or other causes of immunodeficiency.
- Receipt of live attenuated vaccines within 28 days before treatment.
- Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results, including substance abuse, severe psychiatric illness, or social factors.
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
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Decai Yu, +8615996257605, lbhnju@163.com
About this study
Official title: A Prospective Phase II Study of Fatty Acid Degradation (FAD) Subtype-Guided Comprehensive Therapy for Unresectable Hepatocellular Carcinoma
This study is a prospective, multicenter Phase II trial evaluating a personalized treatment strategy for patients with unresectable hepatocellular carcinoma (HCC). The study uses a metabolic classification system called the fatty acid degradation (FAD) subtype to guide therapy selection. Patients will be assigned to different treatment groups based on their tumor's FAD subtype, determined through RNA-seq analysis of the tumor tissue obtained from liver biopsy.
Read the detailed description
This prospective, multicenter Phase II study evaluates a precision-medicine treatment strategy for unresectable hepatocellular carcinoma (HCC) using a metabolic classification system based on fatty acid degradation (FAD). Prior translational research has shown that HCC exhibits heterogeneous metabolic phenotypes, and that tumors with distinct FAD signatures demonstrate different immune microenvironments and therapeutic sensitivities. Building on these findings, this study applies FAD subtype profiling in clinical practice to guide individualized treatment selection.
All enrolled patients will undergo tumor tissue analysis for transcriptomic assessment and FAD scoring. When tumor tissue is not immediately obtainable, MRI fat-fraction measurement may be used temporarily to facilitate enrollment, with tissue-based classification performed afterward. Based on the predefined FAD subtypes (F1, F2, and F3), patients will be allocated to tailored therapeutic strategies designed to align with each subtype's metabolic and microenvironmental characteristics.
Patients with F1 or F2 subtypes will receive systemic therapy with camrelizumab and apatinib, reflecting prior evidence that these subtypes may benefit from immunotherapy combined with anti-angiogenic therapy. Patients with the F3 subtype that characterized by enhanced lipid metabolic activity will receive TACE in addition to camrelizumab and apatinib.
Treatment is delivered in 3-week cycles, with imaging assessments performed regularly to evaluate tumor response. Safety will be closely monitored throughout the study, including immunotherapy-related toxicities, anti-angiogenic drug-associated events, and TACE-related complications. After discontinuation of study treatment, participants will enter a structured follow-up schedule to monitor survival and subsequent treatments.
In addition to evaluating clinical outcomes, the study incorporates exploratory biomarker analyses, including transcriptomics, metabolomics, and imaging-based fat quantification. These analyses aim to improve understanding of how metabolic subtypes influence therapeutic response and resistance mechanisms, and to assess whether MRI-based fat fraction can serve as a noninvasive surrogate for molecular FAD classification.
Overall, this study seeks to translate metabolic phenotyping into clinical decision-making and to determine whether FAD-guided personalized therapy can improve treatment outcomes for patients with unresectable HCC.
- Conditions
- Unresectable Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma (HCC), Liver Cancer Adult
- Being tested
- Camrelizumab Plus Apatinib, TACE Plus Camrelizumab and Apatinib
- Keywords
- Hepatocellular Carcinoma, Fatty Acid Degradation, Metabolic Subtyping, Precision Medicine, Conversion Therapy, Immunotherapy, Anti-angiogenic Therapy, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab Plus ApatinibDrug
Camrelizumab is administered intravenously at 200 mg every 3 weeks, and apatinib is taken orally at 250 mg once daily.
TACE Plus Camrelizumab and ApatinibDrug
Camrelizumab (200 mg IV every 3 weeks) and apatinib (250 mg orally once daily) are administered on the same schedule as the F1/F2 arm. TACE is performed 2-4 weeks after systemic therapy initiation, with up to two treatments per tumor (maximum four sessions total). Apatinib is paused 3-5 days before TACE and restarted 3-5 days afterward.
| Study group | Role | What they receive |
|---|---|---|
| F1/F2 Subtype: Camrelizumab Plus Apatinib | Experimental | Participants whose tumors are classified as F1 or F2 based on the fatty acid degradation (FAD) subtype will receive systemic therapy with camrelizumab and apatinib. Camrelizumab is administered intravenously at 200 mg every 3 weeks, and apatinib is taken orally at 250 mg once daily. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned treatment duration. Imaging assessments are conducted every 6 weeks to evaluate tumor response. Receives: Drug: Camrelizumab Plus Apatinib |
| F3 Subtype: TACE Plus Camrelizumab and Apatinib | Experimental | Participants with the F3 metabolic subtype, characterized by high fatty acid degradation activity, will receive transarterial chemoembolization (TACE) in addition to systemic therapy. Camrelizumab (200 mg IV every 3 weeks) and apatinib (250 mg orally once daily) are administered on the same schedule as the F1/F2 arm. TACE is performed 2-4 weeks after systemic therapy initiation, with up to two treatments per tumor (maximum four sessions total). Apatinib is paused 3-5 days before TACE and restarted 3-5 days afterward. Treatment continues until disease progression, unacceptable toxicity, or discontinuation for clinical reasons. Imaging assessments occur every 6 weeks. Receives: Drug: TACE Plus Camrelizumab and Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by imaging every 6 weeks. ORR will be calculated separately for each FAD subtype cohort (F1/F2 and F3).
Measured: From first dose until first documented disease progression or death, whichever occurs first, assessed up to 24 months.
Secondary outcomes (7)
Objective Response Rate (ORR) by mRECIST
ORR defined as the proportion of participants achieving complete response or partial response according to mRECIST criteria.
Measured: From first dose until first documented disease progression or death, whichever occurs first, assessed up to 24 months.
Disease Control Rate (DCR)
DCR is defined as the proportion of participants achieving complete response, partial response, or stable disease according to RECIST v1.1.
Measured: From first dose until first documented disease progression or death, whichever occurs first, assessed up to 24 months.
Progression-Free Survival (PFS)
PFS will be estimated using RECIST v1.1 criteria and assessed every 6 weeks.
Measured: From first dose until radiographic disease progression or death, whichever occurs first, assessed up to 24 months.
Overall Survival (OS)
OS is defined as the time from study treatment initiation to death from any cause.
Measured: From first dose until death from any cause, assessed up to 24 months.
Duration of Response (DoR)
DoR applies to participants achieving CR or PR per RECIST v1.1.
Measured: From first documented response (CR or PR) until disease progression or death, whichever occurs first, assessed up to 24 months.
Conversion-to-Surgery or Local Ablative Therapy Rate
Proportion of participants converted from unresectable to resectable disease or eligible for curative local therapy based on multidisciplinary assessment.
Measured: Throughout study treatment, up to 24 months
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be evaluated according to CTCAE v5.0; TACE-related complications will be described separately for the F3 cohort.
Measured: From first dose through 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unresectable Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YU DE CAI, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Decai Yu, Doctor, Study chair, the Affiliated Drum Tower Hospital, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314372
- Sponsor's protocol ID
- FAD-HCC-001
- Acronym
- FAD-HCC-001
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study involves genomic, transcriptomic, and clinical imaging data that may pose risks to participant privacy, and data sharing is not planned.
Publications
Li B, Wen J, Xu Z, Yan P, Han B, Yu D. Comprehensive analysis of transcriptomic biomarkers for predicting response to atezolizumab plus bevacizumab immunotherapy in hepatocellular carcinoma. Clin Mol Hepatol. 2025 Jan;31(1):e31-e34. doi: 10.3350/cmh.2024.0628. Epub 2024 Sep 20. No abstract available.
PubMed 39300923Li B, Li Y, Zhou H, Xu Y, Cao Y, Cheng C, Peng J, Li H, Zhang L, Su K, Xu Z, Hu Y, Lu J, Lu Y, Qian L, Wang Y, Zhang Y, Liu Q, Xie Y, Guo S, Mehal WZ, Yu D. Multiomics identifies metabolic subtypes based on fatty acid degradation allocating personalized treatment in hepatocellular carcinoma. Hepatology. 2024 Feb 1;79(2):289-306. doi: 10.1097/HEP.0000000000000553. Epub 2023 Aug 7.
PubMed 37540187
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Fatty Acid Degradation (FAD) Subtype-Guided Comprehensive Therapy for Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07314372
- Acronym / sponsor ID
- FAD-HCC-001 / FAD-HCC-001
- Conditions
- Unresectable Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma (HCC), Liver Cancer Adult
- Keywords
- Hepatocellular Carcinoma, Fatty Acid Degradation, Metabolic Subtyping, Precision Medicine, Conversion Therapy, Immunotherapy, Anti-angiogenic Therapy, TACE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Jan 2026 (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 prospective, multicenter Phase II trial evaluating a personalized treatment strategy for patients with unresectable hepatocellular carcinoma (HCC). The study uses a metabolic classification system called the fatty acid degradation (FAD) subtype to guide therapy selection. Patients will be assigned to different treatment groups based on their tumor's FAD subtype, determined through RNA-seq analysis of the tumor tissue obtained from liver biopsy.
Detailed description
This prospective, multicenter Phase II study evaluates a precision-medicine treatment strategy for unresectable hepatocellular carcinoma (HCC) using a metabolic classification system based on fatty acid degradation (FAD). Prior translational research has shown that HCC exhibits heterogeneous metabolic phenotypes, and that tumors with distinct FAD signatures demonstrate different immune microenvironments and therapeutic sensitivities. Building on these findings, this study applies FAD subtype profiling in clinical practice to guide individualized treatment selection.
All enrolled patients will undergo tumor tissue analysis for transcriptomic assessment and FAD scoring. When tumor tissue is not immediately obtainable, MRI fat-fraction measurement may be used temporarily to facilitate enrollment, with tissue-based classification performed afterward. Based on the predefined FAD subtypes (F1, F2, and F3), patients will be allocated to tailored therapeutic strategies designed to align with each subtype's metabolic and microenvironmental characteristics.
Patients with F1 or F2 subtypes will receive systemic therapy with camrelizumab and apatinib, reflecting prior evidence that these subtypes may benefit from immunotherapy combined with anti-angiogenic therapy. Patients with the F3 subtype that characterized by enhanced lipid metabolic activity will receive TACE in addition to camrelizumab and apatinib.
Treatment is delivered in 3-week cycles, with imaging assessments performed regularly to evaluate tumor response. Safety will be closely monitored throughout the study, including immunotherapy-related toxicities, anti-angiogenic drug-associated events, and TACE-related complications. After discontinuation of study treatment, participants will enter a structured follow-up schedule to monitor survival and subsequent treatments.
In addition to evaluating clinical outcomes, the study incorporates exploratory biomarker analyses, including transcriptomics, metabolomics, and imaging-based fat quantification. These analyses aim to improve understanding of how metabolic subtypes influence therapeutic response and resistance mechanisms, and to assess whether MRI-based fat fraction can serve as a noninvasive surrogate for molecular FAD classification.
Overall, this study seeks to translate metabolic phenotyping into clinical decision-making and to determine whether FAD-guided personalized therapy can improve treatment outcomes for patients with unresectable HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F1/F2 Subtype: Camrelizumab Plus Apatinib | Experimental | Drug: Camrelizumab Plus ApatinibParticipants whose tumors are classified as F1 or F2 based on the fatty acid degradation (FAD) subtype will receive systemic therapy with camrelizumab and apatinib. Camrelizumab is administered intravenously at 200 mg every 3 weeks, and apatinib is taken orally at 250 mg once daily. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned treatment duration. Imaging assessments are conducted every 6 weeks to evaluate tumor response. |
| F3 Subtype: TACE Plus Camrelizumab and Apatinib | Experimental | Drug: TACE Plus Camrelizumab and ApatinibParticipants with the F3 metabolic subtype, characterized by high fatty acid degradation activity, will receive transarterial chemoembolization (TACE) in addition to systemic therapy. Camrelizumab (200 mg IV every 3 weeks) and apatinib (250 mg orally once daily) are administered on the same schedule as the F1/F2 arm. TACE is performed 2-4 weeks after systemic therapy initiation, with up to two treatments per tumor (maximum four sessions total). Apatinib is paused 3-5 days before TACE and restarted 3-5 days afterward. Treatment continues until disease progression, unacceptable toxicity, or discontinuation for clinical reasons. Imaging assessments occur every 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Adults ≥18 years of age who voluntarily agree to participate and sign informed consent.
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC).
- Unresectable or not suitable for curative local therapy, or progression after prior surgery or local therapy.
- BCLC stage B or C.
- No prior systemic therapy for HCC.
Key exclusion criteria (18 listed)
- Non-HCC primary liver cancers (e.g., cholangiocarcinoma, combined HCC-CCA).
- F3 subtype without liver lesions on imaging.
- Clinically significant ascites requiring therapeutic intervention, or uncontrolled pleural/pericardial effusion.
- Interstitial lung disease, pneumonitis requiring steroids, or active pulmonary infection.
- Active or history of autoimmune disease requiring systemic treatment (exceptions allowed per protocol, e.g., controlled hypothyroidism).
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 |
|---|---|---|
| Camrelizumab Plus ApatinibCamrelizumab is administered intravenously at 200 mg every 3 weeks, and apatinib is taken orally at 250 mg once daily. | Drug | F1/F2 Subtype: Camrelizumab Plus Apatinib |
| TACE Plus Camrelizumab and ApatinibCamrelizumab (200 mg IV every 3 weeks) and apatinib (250 mg orally once daily) are administered on the same schedule as the F1/F2 arm. TACE is performed 2-4 weeks after systemic therapy initiation, with up to two treatments per tumor (maximum four sessions total). Apatinib is paused 3-5 days before TACE and restarted 3-5 days afterward. | Drug | F3 Subtype: TACE Plus Camrelizumab and Apatinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: From first dose until first documented disease progression or death, whichever occurs first, assessed up to 24 months.
ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by imaging every 6 weeks. ORR will be calculated separately for each FAD subtype cohort (F1/F2 and F3).
7 secondary outcomes
Objective Response Rate (ORR) by mRECIST
Time frame: From first dose until first documented disease progression or death, whichever occurs first, assessed up to 24 months.
Disease Control Rate (DCR)
Time frame: From first dose until first documented disease progression or death, whichever occurs first, assessed up to 24 months.
Progression-Free Survival (PFS)
Time frame: From first dose until radiographic disease progression or death, whichever occurs first, assessed up to 24 months.
Overall Survival (OS)
Time frame: From first dose until death from any cause, assessed up to 24 months.
Duration of Response (DoR)
Time frame: From first documented response (CR or PR) until disease progression or death, whichever occurs first, assessed up to 24 months.
Conversion-to-Surgery or Local Ablative Therapy Rate
Time frame: Throughout study treatment, up to 24 months
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose through 90 days after last dose
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 Jan 2026.
- Background: PubMed 39300923Li B, Wen J, Xu Z, Yan P, Han B, Yu D. Comprehensive analysis of transcriptomic biomarkers for predicting response to atezolizumab plus bevacizumab immunotherapy in hepatocellular carcinoma. Clin Mol Hepatol. 2025 Jan;31(1):e31-e34. doi: 10.3350/cmh.2024.0628. Epub 2024 Sep 20. No abstract available.
- Background: PubMed 37540187Li B, Li Y, Zhou H, Xu Y, Cao Y, Cheng C, Peng J, Li H, Zhang L, Su K, Xu Z, Hu Y, Lu J, Lu Y, Qian L, Wang Y, Zhang Y, Liu Q, Xie Y, Guo S, Mehal WZ, Yu D. Multiomics identifies metabolic subtypes based on fatty acid degradation allocating personalized treatment in hepatocellular carcinoma. Hepatology. 2024 Feb 1;79(2):289-306. doi: 10.1097/HEP.0000000000000553. Epub 2023 Aug 7.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study involves genomic, transcriptomic, and clinical imaging data that may pose risks to participant privacy, and data sharing is not planned.
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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.
Decai Yu, Doctor study chair
the Affiliated Drum Tower Hospital, Medical School of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab Plus Apatinib and TACE Plus Camrelizumab and Apatinib in people with Unresectable Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma (HCC), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 22 inclusion and 18 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 Jan 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.
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?
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 Decai Yu, Doctor (+86-025-68182222 ext. 60911, yudecai@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From first dose until first documented disease progression or death, whichever occurs first, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07314372, which also lists 2 linked publications.
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 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.