Biomarker and Mechanism Study of Systemic Therapy in Unresectable HCC

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT07786792
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Systemic therapy — DRUG
    Including regimens such as Atezolizumab + Bevacizumab, Nivolumab + Ipilimumab.
  • Local therapy — PROCEDURE
    Including therapy such as TACE, HAIC

Study Details

The goal of this observational study is to evaluate the safety and efficacy of systemic therapies and identify predictive molecular biomarkers in patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC). The main questions it aims to answer are:What is the objective response rate (ORR) of systemic therapy regimens in this patient population? Which 3-4 specific biomarkers (including tumor or peripheral blood-derived genes, proteins, ctDNA, and immune cell subsets) can reliably predict the efficacy of systemic treatment?

Key Dates

First listed
Aug 26, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Systemic Therapy Cohort
    Patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC) receiving systemic therapy alone.
  • Arm: TACE/HAIC + Systemic Therapy Cohort
    Patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC) receiving transcatheter arterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with systemic therapy.

Primary Outcome Measure

Objective Response Rate (ORR) Assessed by RECIST v1.1 and HCC mRECIST Criteria [ Time Frame: Up to 2 years (assessed every 8 ± 2 weeks) ]

Central Contacts

Find similar trials

Nationwide
Liver cancer trialsOncology trialsGI oncology trialsHepatology trials

Related Studies