NCT05823584

Cell-free DNA From Junction of Hepatitis B Virus Integration in HCC Patients for Monitoring Post-resection Recurrence

Completed Last updated 10 April 2024

What this trial tests

trial in Hepatocellular Carcinoma in 207 participants. Completed in 31 December 2023.

Timeline

22 December 2019

Primary endpoint
21 July 2023

31 December 2023

Quick facts

Lead sponsor	TCM Biotech International Corp.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	207
Start date	22 December 2019
Primary completion	21 July 2023
Estimated completion	31 December 2023
Sites	1 location across Taiwan

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

TCM Biotech International Corp. — full company profile →

Who can join

20 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HBV DNA integration has been found in the chromosomes of about 90% of HBV-related HCC and the integration site is unique to individual HCC. The virus-host chimera DNA (vh-DNA) from HBV integration sites in HCC a reliable evidence even in the patient with a tiny tumor which is not large enough to be detected by the image scan.

The goal of this observational study is to compare the prediction ability of vh-DNA with the other biomarkers for monitoring the recurrent of HBV-related HCC. The main questions that aim to answer are the sensitivity and specificity of vh-DNA/AFP/ALP-L3/PIVKA-II/TERTC2280 when the gold standard is the guideline of HCC diagnosis.

The surgical tissues and plasma samples from the participants would be collected undergoing the HCC recession surgery when joining the study at the beginning, in order to identify the HBV integration in tumor by Capture NGS and quantify the specific vh-DNA in plasma by ddPCR as personalized biomarkers for minimal residual disease (MRD) monitoring. Moreover, the consistency of vh-DNA from tumor will be validated by pre-operative plasma.

Then the participants will be asked to performed the visit at 2, 5, 8, 11, 14 months after the HCC recession surgery. The plasma sample for vh-DNA/AFP/ AFP-L3/ PIVKA-II/ TERTp C228T testing and the image data from ultrasound, CT or MRI would also be collected at these visits. When the vh-DNA testing result is positive and there is no recurrence at 14 months after the HCC recession surgery, some participants will be asked to followed at 17, 20 months.

Researcher will compare the sensitivity, specificity and predict day of vh-DNA with AFP/ AFP-L3/ PIVKA-II/ TERTp C228T as a biomarker for HCC surveillance. The true value of this novel HBV chimera vh-DNA will be revealed. The results will also support to use for monitoring post-operative recurrence.

In addition, the investigators will explore the performance of TERTp C228T mutation from non-HBV HCC patients. As a different target of ctDNA for HCC, TERTp C228T will be identified using surgical tissues from HCC patients, and plasma samples from the same patient before/after operation will be tested by ddPCR . It will be evaluated that TERTp C228T is predictive or not for recurrence monitoring of HCC.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing.
   Kobayashi S, Nakamura Y, Hashimoto T, Bando H, et al · · 2025 · cited 6× · PMID 39920551 · DOI 10.1007/s10147-024-02683-0