Immunophenotype of PBMC to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma

NCT06777628 | Recruiting DMC

• 1 other identifier: Immunecheck
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study is aimed to test the performance of a simple, easy, reproducible cytofluorimetric assay to complement imaging studies for:

• predicting response to immune-therapeutic regimens in HCC in the early phase of treatment,
• to rule out pseudo-progression,
• to early predict the escape from effectiveness of treatment.

Conditions

Liver Cancer, Adult

Keywords

immunophenotype; HCC patients; immunotherapy

Outcome Measures

Primary Outcomes (1)

• To find predictive biomarkers of response to immunotherapy in HCC

  Sensitivity and specificity of CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, TIGIT+, CD8+PD1+, CD8+PDL1+ peripheral lymphocytes and granulocytes for tumor response prediction according to RECIST 1.1 criteria

  at 3 month

Secondary Outcomes (1)

• To compare the transcriptomic signatures of PBMC of responders and non-responders

  At 3 months

Study Arms (1)

HCC patients

Patients with advanced HCC undergoing immunotherapy

Drug: Immunochemotherapy combined with antiangiogenic

Interventions

Immunochemotherapy combined with antiangiogenic DRUG

Immunochemotherapy combined with antiangiogenic

HCC patients

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

patients with advanced hepatocellular carcinoma

You may qualify if:

• age ≥ 18 years
• diagnosis of HCC
• execution of laboratory tests and subsequent treatments and follow-up at our center.
• obtained written informed consent to the study participation

You may not qualify if:

• immune-related concomitant diseases
• HIV infection

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS-Azienda Ospedaliero-Universitaria di Bologna

Bologna, Laura Gramantieri, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood mononuclear cells separated by Ficoll gradient

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Angiogenesis Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Growth Inhibitors; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Laura Gramantieri

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Gramantieri, MD

CONTACT

0512142579; laura.gramantieri@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 16, 2025
• Study Start: September 15, 2024
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2028
• Last Updated: January 16, 2025

Record last verified: 2024-09

Locations

IT (1)