NCT06408753Completed
Plasma Biomarker in Predicting Response and Toxicity in HCC Patients Treated With Checkpoint Inhibitors With or Without SBRT
Plasma Biomarker in Predicting Response and Toxicity in Hepatocellular Carcinoma Patients Treated With Checkpoint Inhibitors With or Without Sterotatic Body Radiotherapy
Source: ClinicalTrials.gov · Last updated 10 May 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 9 Sept 2021
- Start date
- 1 Nov 2019
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- The University of Hong Kong
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06408753
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 1 Nov 2019 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 1\. Based on the inclusion criteria above. Any eligibility factors that do not fit the inclusion criteria will be considered as ineligible subjects.
Who the study is looking for
- First Cohort (SBRT+IO):
- Unresectable HCC confirmed by multi-disciplinary team
- Tumor size 5-15cm
- Number of lesion(s) ≤ 3
- No main portal vein or inferior vena cava thrombosis
- ECOG performance status 0-1
- Child-Pugh class A-B7
- Liver volume minus gross tumor volume \> 700ml
- Adequate organ function
- No prior systemic therapy, immunotherapy, TACE, radiotherapy, or radio-embolization
- Second Cohort (IO alone):
- BCLC stage C HCC
- ECOG performance status 0-1
- Child-Pugh class A5-B9
- Adequate organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Clinical Oncology Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.