Plasma Biomarker in Predicting Response and Toxicity in HCC Patients Treated With Checkpoint Inhibitors With or Without SBRT

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06408753
• Other study ID #: UW 19-857
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: March 27, 2024

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable
• Stereotactic Body Radiotherapy

Intervention

Procedure:
• sterotatic body radiotherapy
checkpoint inhibitors with or without sterotatic body radiotherapy

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

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