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

NCT06408753 | Completed

• 1 other identifier: UW 19-857
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hepatocellular Carcinoma Non-resectable; Stereotactic Body Radiotherapy

Keywords

SBRT; immune checkpoint inhibitors

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Serum Cytokine profile

  from the date of first study treatment to the date of last study treatment, an average of 3 years

Interventions

sterotatic body radiotherapy PROCEDURE

checkpoint inhibitors with or without sterotatic body radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the inclusion criteria above. Any eligibility factors that do not fit the inclusion criteria will be considered as ineligible subjects.

You may qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology

Hong Kong, Hong Kong

Location

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Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: May 10, 2024
• Study Start: November 1, 2019
• Primary Completion: November 30, 2023
• Study Completion: March 27, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

HK (1)