Clinical trial · Observational
Identification of an Immune Single Cell Transcriptomic Profile of Responder and Non-responder Hepatocellular Carcinoma Patients Treated With Immune-checkpoint Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aims to analyze blood samples from patients with advanced hepatocellular carcinoma who are receiving systemic treatment with immunotherapy. The objective is to determine whether treatment exposure leads to changes in the transcriptomic patterns of peripheral blood mononuclear cells (PBMCs), if these changes are associated with treatment response, and whether certain pre-treatment transcriptomic signatures can predict response to treatment. As an exploratory objective, PBMCs derived from patients exposed to immune checkpoint inhibitors will be co-cultured with their paired tumor cells in organoid cultures. This aims to assess whether these preclinical 3D models correlate with clinical outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced HCC Treated by Systemic Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Single cohort
- description
- Patients treated withi immune-check point inhibitor-based combinations as first-line treatment for advanced HCC
Primary outcomes (1)
- measure
- Analysis of the single cell profiling of peripheral blood mononuclear cells in patients with HCC treated with immunotherapy pre-therapy (T0) and the 3 months post-therapy (T3) to define if a difference between the two time points exists.
- timeFrame
- From enrollment untill 3 months after treatment start, (up to 120 days from study inclusion)
- description
- The single cell profiling of peripheral blood mononuclear cells in patients with HCC treated with immunotherapy will be analised at two type points: before starting therapy(T0), and the 3 months post-therapy (T3). The difference of single cell profiling of the two paired time-points will be analysed.
Secondary outcomes (2)
- measure
- Correlation between transcriptome signature at baseline and treatment outcomes.
- timeFrame
- From enrollment to the time of best response to treatment, up to 24 months from enrollement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. diagnosis of advanced HCC treated with atezolizumab plus bevacizumab or tremelimumab single dose plus durvalumab (STRIDE regimen) as first-line treament 2. age ≥18 and \<90 years at time of signing informed consent 3. Signed Informed Consent Form Exclusion Criteria: 1. Life expectancy of \<12 months due to concomitant diseases 2. Active or history of autoimmune disease or immune deficiency on inflammatory chronic diseases 3. Ongoing drug abuse 4. History of malignancy other than HCC within 3 years prior to study entry with the following exception: 1. Completely resected malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate 90%) and without evidence of recurrence for \> 3 years prior to study entry 2. adequately treated non-melanoma skin carcinoma or lentigo maligna without evidence of metastases. 3. adequately treated carcinoma in situ of the cervix without evidence of recurrence 4. localised prostate cancer 5. adequately treated non invasive or in situ urothelial cancers 5. evidence or history of positive HIV test 6. inability to comply with the study protocol, in the investigator's judgment
References
Publications (0)
Data not yet available