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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Camrelizumab is administered intravenously at 200 mg every 3 weeks, and apatinib is taken orally at 250 mg once daily.
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.
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
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).
Time frame: From first dose until first documented disease progression or death, whichever occurs first, assessed up to 24 months.
Objective Response Rate (ORR) by mRECIST
ORR defined as the proportion of participants achieving complete response or partial response according to mRECIST criteria.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Proportion of participants converted from unresectable to resectable disease or eligible for curative local therapy based on multidisciplinary assessment.
Time frame: 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.
Time frame: From first dose through 90 days after last dose
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