CClinicalTrials.gg
RecruitingNCT06382103Updated Mar 26, 2025

Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy

An observational study in Hepatocellular Carcinoma, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Shanghai Zhongshan Hospital · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
240
Sex
All
01

Study summary

Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection.

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 240 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will enroll male and female subjects with HCC treated with definitive surgery,with or without neoadjuvant therapy.

Inclusion criteria

  • Patients with a first diagnosis of HCC.
  • Patients with HCC who are to undergo surgical treatment, with or without neoadjuvant therapy.
  • Ability to obtain tissue sample for ctDNA analysis and detectable baseline ctDNA level.

Exclusion criteria

Exclusion Criteria:

  • Patients with secondary liver cancer, or intrahepatic cholangiocarcinoma.
  • Any other concurrent malignancy.
  • History of organ transplant or hepatic encephalopathy.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testctDNA monitoring

    The ctDNA level will be measured using tumor-informed (Signatera platform) and tumor-naived (fragmentomes measurement) assay.

  • Diagnostic testPlasma proteomic analysis

    plasma protein level will be measured via Proximity Extension Assay and LC-MS based proteomic analysis

06

What researchers measure

Primary outcomes

  1. Correlation between ctDNA level and recurrence-free survival (RFS)

    ctDNA measurements will be made at baseline and 1 months, 3 months, 6 months, 12 months after surgery. RFS will be assessed by standard radiographic imaging.

    Time frame: 1 years

  2. Correlation between specific plasma protein expression level and recurrence-free survival (RFS)

    plasma proteomic measurements will be made at baseline and 1 months, 3 months, 6 months, 12 months after surgery. RFS will be assessed by standard radiographic imaging.

    Time frame: 1 years

Secondary outcomes

  1. Correlation between tumor mutation numbers and recurrence-free survival (RFS)

    Patients with available tumor tissues were sequenced to identify their specific tumor variants.The correlation of mutation numbers and RFS will be analysis.

    Time frame: 1 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06382103
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Apr 24, 2024
Start date
May 15, 2024
Primary completion
May 20, 2025 (estimated)
Completion
May 20, 2026 (estimated)
Last update
Mar 26, 2025

Study contacts

Huichuan Sun
Contact
sun.huichuan@zs-hospital.sh.cn
+86-21-64041990

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion