Immunophenotype of PBMC to Early Predict Response to Immu... | NCT06777628

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

NCT06777628

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Recruiting

Last Update Posted

Jan 16, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Liver Cancer, Adult

Interventions

Immunochemotherapy combined with antiangiogenic

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2024Actual

Primary Completion Date

Oct 15, 2026Estimated

Completion Date

Oct 15, 2028Estimated

First Submitted Date

Nov 28, 2024

First Submission Date that Met QC Criteria

Jan 14, 2025

First Posted Date

Jan 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2025

Last Update Posted Date

Jan 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

To assess the accuracy of biomarkers from an immunophenotypic test (CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, CD8+PD1+, CD8+PDL1+ peripheral lymphocyte populations and circulating granulocytes) in predicting the response to immuno-therapy in patients affected by hepatocellular carcinoma (HCC).
To compare the transcriptomic signatures of peripheral blood mononuclear cells (PBMC) of responders and non-responders (assessed at the first imaging study).

RNAseq data will be validated by RT-PCR in independent prospective cohorts.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCC patients		Patients with advanced HCC undergoing immunotherapy	Drug: Immunochemotherapy combined with antiangiogenic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunochemotherapy combined with antiangiogenic	Drug	Immunochemotherapy combined with antiangiogenic	HCC patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To compare the transcriptomic signatures of PBMC of responders and non-responders	Tumor response according to RECIST 1.1 criteria	At 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

immune-related concomitant diseases
HIV infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with advanced hepatocellular carcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laura Gramantieri, MD	Contact	0512142579		laura.gramantieri@aosp.bo.it

Overall Officials

Name	Affiliation	Role
Laura Gramantieri	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS-Azienda Ospedaliero-Universitaria di Bologna	Recruiting	Bologna	Laura Gramantieri	40138	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020533	Angiogenesis Inhibitors

Ancestor Terms

ID	Term
D043924	Angiogenesis Modulating Agents
D006133	Growth Substances
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided