29-Gene Liver Cancer Subtype and Immunotherapy Effectiveness
ConditionPrimary Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJunjie Xu
About this trial
This clinical study plans to include 350 liver cancer patients from 10 tertiary hospitals nationwide, starting from August 1, 2025, at multiple centers such as the affiliated Run Run Shaw Hospital of Zhejiang University School of Medicine (the leading unit). They will be divided into a new typing queue (100 cases) and another typing queue (250 cases) using the 29 gene set algorithm. The study will collect tumor tissue samples obtained from surgical resection or puncture of patients (meeting the requirements of sample size and tumor cell proportion), perform RNA seq transcriptome sequencing, and extract patient baseline data, clinical pathological characteristics, laboratory test results, treatment information, and follow-up data from the hospital medical record system. The main objective of this study is to observe the disease progression time (TTP) and objective response rate (ORR) of patients after receiving targeted combined immunotherapy. The secondary observations include progression free survival (PFS), overall survival (OS), dynamic changes in tumor markers, liver function status, and survival after progression. The aim is to analyze the correlation between the 29 gene based new subtype of liver cancer and the efficacy of immunotherapy, providing a basis for precise diagnosis and treatment of liver cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old.
Patients who visited multiple centers including Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (the leading center) and were diagnosed with primary hepatocellular carcinoma by surgical pathological histology.
They received targeted drug combined with immune checkpoint inhibitor treatment after the specimen collection time point (post - surgery or post - puncture) (that is: local treatments such as TACE, ablation, etc. are allowed before the start of targeted - immunotherapy combination treatment, but an interval of ≥4 weeks from the targeted - immunotherapy treatment is required).
Had measurable tumor lesions at the observation start point (according to RECIST 1.1 criteria), and the tumor response status (including complete response [CR], partial response [PR], stable disease [SD] or progressive disease [PD]) could be judged by imaging examination during the observation (such as post - treatment evaluation).
Disqualifiers
Local treatment was initiated before the start of targeted - immunotherapy combination treatment, and the local treatment continued into the targeted - immunotherapy treatment period (that is, there was an overlap between local treatment and targeted - immunotherapy treatment or the interval was < 4 weeks).
Complicated with other active malignant tumors (except for those with cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma with no recurrence for more than 5 years after surgery).
Had a history of autoimmune diseases and currently still needed to use systemic glucocorticoids (prednisone > 10mg/day) or other immunosuppressive therapies.
Pregnant or lactating women, or patients planning to become pregnant during the study.
Trial population
Adult patients (≥18 years) with pathologically confirmed primary hepatocellular carcinoma, with accessible tumor samples (surgical/frozen biopsy tissues ≥3g or qualified puncture specimens). They receive targeted-immunotherapy after sample collection, with measurable lesions (RECIST 1.1). Local treatments are allowed if not overlapping with target-immunotherapy (interval ≥4 weeks). Excluded: active malignancies/organ dysfunction/uncontrolled infections/autoimmune diseases/pregnancy. All provide informed consent.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Observational study of 29 - gene - defined HCC subtypes and immunotherapy responsiveness correlation
Other interventionThis is a non - interventional observational study. We will stratify patients with hepatocellular carcinoma (HCC) based on transcriptome sequencing of their tumor samples, specifically using a 29 - gene signature to classify them into different subtypes. Without interfering with patients' existing immunotherapy regimens (which are determined by clinical practice), we will retrospectively collect and analyze data on treatment responses. The goal is to explore the correlation between the 29 - gene - based HCC subtypes and responsiveness to immunotherapy, focusing on differences in outcomes like objective response rate (ORR) and progression - free survival (PFS) across subtypes. This study distinguishes itself by emphasizing observational analysis of pre - existing treatment patterns rather than implementing active interventions, aiming to provide insights into personalized immunotherapy for HCC through genetic subtyping.
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Novel subtype cohort of HCC1 intervention
Group B: Other HCC subtypes cohort1 intervention
Trial outcomes
Primary outcomes
1
Disease Progression Time (TTP)
Time from initiation of target-ICI therapy to first documentation of disease progression per mRECIST criteria. Progression includes: Target lesions: ≥20% increase in sum of arterial-enhancing diameters (vs baseline) + absolute increase ≥5mm; Non-target lesions: New lesions or definite progression of existing non-target lesions; Distant metastasis: New lung, bone, or lymph node metastases.
Time frame
From target-ICI therapy start, assessed at baseline, Week 8, 16, 24, progression/termination. Max 24 months through study end. Data for all time points.2
Objective Response Rate (ORR)
Proportion of patients achieving Complete Response (CR: disappearance of arterial enhancement in all target lesions) or Partial Response (PR: ≥30% reduction in sum of target lesion diameters).
Time frame
From target-ICI therapy start, per regimen: Week 8, 16, 24, progression/termination. New regimens: same time points (reset). Max 24 months through study end. Data for all.Secondary outcomes
1
Progression - Free Survival (PFS)
Time from target-ICI therapy start to first disease progression (per mRECIST) or any-cause death (whichever occurs first).
Time frame
From target-ICI therapy start, assessed via imaging (baseline, every 8 weeks) and survival follow-up. Max 24 months through study end. Data for all time points.2
Overall Survival (OS)
Time from target-ICI therapy start to any-cause death; lost-to-follow-up patients censored at last follow-up.
Time frame
From target-ICI therapy start, assessed via regular follow-up. Max 24 months through study end. Survival curves; data for all time points.3
Alpha-FetoProtein (AFP)
Monitoring of alpha-fetoprotein (AFP) for ≥20% increase (vs baseline) lasting ≥4 weeks, combined with imaging to predict progression risk.
Time frame
From target-ICI therapy start, assessed at baseline, every 4 weeks. Max 24 months. Data for all time points.4
Protein Induced by Vitamin K Absence or Antagonist II (PIVKA-II)
Monitoring of protein induced by vitamin K absence/antagonist-II (PIVKA-II) for ≥20% increase (vs baseline) lasting ≥4 weeks, combined with imaging to predict progression risk.
Time frame
From target-ICI therapy start, assessed at baseline, every 4 weeks. Max 24 months. Data for all time points.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Junjie Xu
Lead sponsor
Sir Run Run Shaw Hospital
Sponsor institution
Sir Run Run Shaw Hospital
Collaborator
Source ClinicalTrials.gov
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