Clinical trial · Observational
A Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma
Developing a Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma Treated With Radiotherapy: Personalized Cell-free Virus-host Chimera DNA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators will first use our previously collected serum samples and surgical/biopsied tissues from HBV-related HCC patients undergoing radiotherapy. The consistency of junctional clones by Capture NGS needs to be tested between both pre- and post-RT serums, and serial changes in copy numbers of vh-DNA by ddPCR are quantified in the representative cases. The same junction clones from pre-post-RT serums and surgical tissues will be confirmed and the copy number changes of vh-DNA be correlated with RT response and disease-control status. The investigators plan to identify HBV integrations by Capture NGS and quantify the specific vh-DNA by ddPCR as personalized biomarkers from the same-patient serum samples. The investigators will further correlate clinical response and recurrence/metastasis with serial changes of vh-DNA copy numbers. The investigators have been prospectively collecting plasma samples from HBV-related HCC patients before/after RT, at 1, 4, 7 months, and at recurrence/metastasis. The investigators plan to confirm the viable role of pre-/post-RT changes of plasma vh-DNA copies of the same junction clone in post-RT response and prognosis. Moreover, The investigators will explore the recurrent/metastatic tumors arising from the original or a de novo one by identifying their clonality with HBV integration patterns. The true value of this novel HBV chimera vh-DNA will be revealed. The results will also support the consolidative use of personalized vh-DNA for earlier evaluating treatment response after RT, for post-RT disease monitoring, and for differentiating clonality at recurrence to design future clinical trial on combinational treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biomarker | — | UNRESOLVED | — |
| Hepatitis b Virus | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (8)
- measure
- To retrospectively analyze the Capture-NGS analysis from HBV-related HCC patients
- timeFrame
- 2031/01/01
- description
- Capture-NGS analysis and identification of HBV-human junction between pre- and post- RT
- measure
- To retrospectively analyze the Vh-DNA specific PCR from HBV-related HCC patients
- timeFrame
- 2031/01/01
- description
- Vh-DNA specific PCR between pre- and post- RT
- measure
- To retrospectively analyze the serial changes of serum vh-DNA copies of same junction clone from HBV-related HCC patients
- timeFrame
- 2031/01/01
- description
- Treatment response between pre- and post- RT
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients diagnosed with HCC by dynamic image criteria and/or biopsy 2. HBsAg (+) 3. Child-Turcotte-Pugh (CTP) class A-B liver function 4. Radiotherapy to liver tumor as the main treatment Exclusion Criteria: 1. Child-Turcotte-Pugh (CTP) class C liver functiECOG performance status score \>2 2. Has had prior radiotherapy to the proposed treatment field. 3. \< 18 years old
References
Publications (0)
Data not yet available