Clinical trial · Observational
Biomarker Analyses in Hepatocellular Carcinoma (HCC) Patients Treated With TheraSphere®
Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®
NCT03203837CI-TRIAL-00047026terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding Discontinued due to low accrual rate
Summary
Brief summary (as posted)
To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HCC patients
- description
- HCC patients treated with radioembolization. Plasma collection will be performed at 7 timepoints in relation to treatment.
- interventionNames
- Other: Plasma collection
Primary outcomes (1)
- measure
- Percentage change in angiogenic, inflammatory and immune biomarkers
- timeFrame
- 2 years
- description
- The percent of change at 7 different timepoints for the following biomarkers will be calculated: Ang-2, FGFb, HB-EGF, HGF, PDGF-BB, PIGF, SDF-1, VEGF, VEGFC, IFNg, IL-1a, IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, TNFa trimer, CRP, TGFb1, EGFR, PD-1, PD-L1, CD45RA, CD127, HLA-DR, CD62L, CD3, CD8, CD197, CCR7, CD45RO, PD-L2, FOXP3, Perforin, Granzyme, TIA-1, CD14, CD107a, CD25, CD45, CD4, CD20 and CD56+16.
Secondary outcomes (4)
- measure
- Treatment Response- AFP
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have the diagnosis of HCC (biopsy or imaging criteria) * Must have planned lobar TheraSphere treatment * Must be able to give consent * Must have an ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2 * Must have a life expectancy of ≥ 3 months * Women must not be pregnant with an acceptable contraception in premenopausal women * Must be \> 4 weeks since prior radiation * Must be \> 2 weeks since liver surgery * Must be ≥ 2 weeks post radiosensitizing chemotherapy or \> 6 weeks since prior BCNU (carmustine) or Mitomycin-C Exclusion Criteria: * Patients are excluded if they do not meet the inclusion criteria
References
Publications (29)
- BACKGROUNDPoon RT, Ng IO, Lau C, Zhu LX, Yu WC, Lo CM, Fan ST, Wong J. Serum vascular endothelial growth factor predicts venous invasion in hepatocellular carcinoma: a prospective study. Ann Surg. 2001 Feb;233(2):227-35. doi: 10.1097/00000658-200102000-00012. PMID 11176129
- BACKGROUNDNg IO, Lai EC, Fan ST, Ng MM, So MK. Prognostic significance of pathologic features of hepatocellular carcinoma. A multivariate analysis of 278 patients. Cancer. 1995 Dec 15;76(12):2443-8. doi: 10.1002/1097-0142(19951215)76:123.0.co;2-f. PMID 8625069
- BACKGROUNDFinkenzeller G, Marme D, Weich HA, Hug H. Platelet-derived growth factor-induced transcription of the vascular endothelial growth factor gene is mediated by protein kinase C. Cancer Res. 1992 Sep 1;52(17):4821-3. PMID 1511446
- BACKGROUNDStavri GT, Hong Y, Zachary IC, Breier G, Baskerville PA, Yla-Herttuala S, Risau W, Martin JF, Erusalimsky JD. Hypoxia and platelet-derived growth factor-BB synergistically upregulate the expression of vascular endothelial growth factor in vascular smooth muscle cells. FEBS Lett. 1995 Jan 30;358(3):311-5. doi: 10.1016/0014-5793(94)01458-d. PMID 7843420
- BACKGROUNDMann CD, Neal CP, Garcea G, Manson MM, Dennison AR, Berry DP. Prognostic molecular markers in hepatocellular carcinoma: a systematic review. Eur J Cancer. 2007 Apr;43(6):979-92. doi: 10.1016/j.ejca.2007.01.004. Epub 2007 Feb 8. PMID 17291746
- BACKGROUNDWada H, Nagano H, Yamamoto H, Yang Y, Kondo M, Ota H, Nakamura M, Yoshioka S, Kato H, Damdinsuren B, Tang D, Marubashi S, Miyamoto A, Takeda Y, Umeshita K, Nakamori S, Sakon M, Dono K, Wakasa K, Monden M. Expression pattern of angiogenic factors and prognosis after hepatic resection in hepatocellular carcinoma: importance of angiopoietin-2 and hypoxia-induced factor-1 alpha. Liver Int. 2006 May;26(4):414-23. doi: 10.1111/j.1478-3231.2006.01243.x. PMID 16629644