A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma

NCT07117279 | Not Yet Recruiting DMC

• 1 other identifier: TJ-IRB202506074
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to identify early predictors for successful liver cancer treatment conversion. We will track changes in immune cells (CD8+ T-cells) in the blood during chemotherapy infusion (HAIC/TACE) combined with targeted-immunotherapy for 120 patients with unresectable liver cancer. By analyzing blood and tissue samples at multiple timepoints using advanced cell profiling and multi-omics sequencing, we seek to: Determine if early immune cell changes predict tumor shrinkage; Identify tissue biomarkers linked to longer recurrence-free survival; Build a personalized prediction model for treatment outcomes.

Conditions

HCC - Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Proportion of patients achieving tumor shrinkage (≥30% diameter reduction) or complete disappearance on CT/MRI scans, evaluated by RECIST v1.1 criteria. Complete response = 0 visible tumor; Partial response = ≥30% reduction in total tumor size.

  From treatment initiation to 12 weeks after first therapy cycle.

Secondary Outcomes (2)

• Recurrence-Free Survival (RFS)

  From surgery date to first recurrence or death (assessed monthly for 24 months).

• Severe Treatment-Related Side Effects

  From first treatment dose to 30 days after final dose.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with unresectable liver cancer (HCC) who are scheduled to receive HAIC/TACE plus immunotherapy at major hospitals in Shanghai. All participants must have preserved liver function (Child-Pugh A) and at least one measurable tumor. Key requirements include willingness to undergo tumor biopsy before treatment and provide repeated blood samples during therapy. Expected recruitment sources: 1) Liver cancer specialty clinics (majority), 2) Interventional radiology units.

You may qualify if:

• Adults (18-75 years) with histologically confirmed HCC
• At least one measurable lesion ≥10 mm
• Planned HAIC/TACE + immunotherapy regimen
• Child-Pugh class A liver function
• ECOG 0-1
• Signed informed consent

You may not qualify if:

• Prior systemic HCC therapy within 6 months
• Main portal vein tumor thrombosis (VP4)
• Active autoimmune disease requiring immunosuppression
• HIV/HBV/HCV with uncontrolled viral replication
• Pregnancy or refusal of contraception

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08