Hepatocellular Carcinoma Non-resectable Clinical Trial
Official title:
Plasma Biomarker in Predicting Response and Toxicity in Hepatocellular Carcinoma Patients Treated With Checkpoint Inhibitors With or Without Sterotatic Body Radiotherapy
NCT number | NCT06408753 |
Other study ID # | UW 19-857 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | March 27, 2024 |
Verified date | May 2024 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is a prospective study to investigate the biomarkers in predicting treatment outcome and toxicity in hepatocellular carcinoma (HCC) patients receiving immune checkpoint inhibitors with or without stereotactic body radiotherapy (SBRT).
Status | Completed |
Enrollment | 50 |
Est. completion date | March 27, 2024 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: First Cohort (SBRT+IO): 1. Unresectable HCC confirmed by multi-disciplinary team 2. Tumor size 5-15cm 3. Number of lesion(s) = 3 4. No main portal vein or inferior vena cava thrombosis 5. ECOG performance status 0-1 6. Child-Pugh class A-B7 7. Liver volume minus gross tumor volume > 700ml 8. Adequate organ function 9. No prior systemic therapy, immunotherapy, TACE, radiotherapy, or radio-embolization Second Cohort (IO alone): 1. BCLC stage C HCC 2. ECOG performance status 0-1 3. Child-Pugh class A5-B9 4. Adequate organ function Exclusion Criteria: 1. Based on the inclusion criteria above. Any eligibility factors that do not fit the inclusion criteria will be considered as ineligible subjects. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Clinical Oncology | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exosomal PD-L1 level in serum | Increase in level of exosomal PD-L1 may reflect reinvigoration of T-cell activity against cancer cells, thus predicting the treatment efficacy and toxicities in HCC patients received immunotherapy with or without SBRT | from the date of first study treatment to the date of last study treatment, an average of 3 years | |
Primary | Immune profile of peripheral blood mononuclear cells (PBMC) | Immune profile of pre-treatment peripheral blood is predictive of sustained responder of radio-embolization, thus predicting the treatment efficacy and toxicities in HCC patients received immunotherapy with or without SBRT | from the date of first study treatment to the date of last study treatment, an average of 3 years | |
Secondary | Serum Cytokine profile | SBRT activates the host immune system, in particular those achieving clinical response to the combined treatment | from the date of first study treatment to the date of last study treatment, an average of 3 years |
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