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29-Gene Liver Cancer Subtype and Immunotherapy Effectiveness

NCT07100236 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-08-03

No results posted yet for this study

Summary

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.

Conditions

  • Primary Hepatocellular Carcinoma

Interventions

OTHER

Observational study of 29 - gene - defined HCC subtypes and immunotherapy responsiveness correlation

This 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.

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • Junjie Xu

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-05-01
Completion
2027-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100236 on ClinicalTrials.gov