Exploring T Cell Markers for Immunotherapy in Liver Cancer

The Clinical Value of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution in the Immunotherapy of Advanced Primary HCC Patients.

This study is testing if measuring a specific marker on immune cells can help doctors predict how well immunotherapy will work for patients with advanced liver cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: China Three Gorges University, Yichang, China (other)
• Drugs / interventions: Sintilimab, chemotherapy, immunotherapy
• Locations: 1 site (Yichang, Hubei)
• Trial ID: NCT06029829 on ClinicalTrials.gov

What this trial studies

This study investigates the expression of PD-1 on peripheral blood T lymphocytes in patients with advanced hepatocellular carcinoma (HCC) to determine its potential as a predictive marker for immunotherapy efficacy. By analyzing the relationship between PD-1 expression levels and patient survival outcomes after treatment with PD-1/PD-L1 inhibitors, the study aims to enhance patient selection for immunotherapy. Additionally, it will explore the distribution of T cell subsets and their correlation with treatment effectiveness, providing new insights for clinical screening and prognosis assessment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed advanced hepatocellular carcinoma and specific liver function criteria.

Not a fit: Patients with active autoimmune diseases or those who have previously received PD-1 or PD-L1 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the selection of patients for immunotherapy, potentially leading to better treatment outcomes for those with advanced HCC.

How similar studies have performed: While the approach of using PD-1 expression as a predictive marker is being explored in various contexts, this specific investigation in advanced HCC represents a novel application.

Eligibility criteria

Inclusion Criteria:

* Willing to participate in the clinical study, fully understand and be informed about the study, and sign the informed consent form;
* Age between 18 and 75 years, male or female;
* Strictly meet the clinical diagnostic criteria for hepatocellular carcinoma (HCC), confirmed by histology or cytology, with at least one lesion meeting the RECIST 1.1 criteria on CT or MRI examination;
* No prior targeted therapy, immunotherapy, or systemic chemotherapy for liver cancer before admission;
* Child-Pugh A liver function; Barcelona Clinic Liver Cancer (BCLC) stage B or C;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Normal function of major organs;
* Expected survival time of at least 12 weeks or more.

Exclusion Criteria:

* Patients who have not previously received treatment with Sintilimab or any other PD-L1 or PD-1 antagonist;
* Patients with any active autoimmune disease or a history of autoimmune disease, or a history of immunodeficiency;
* Patients requiring the use of immunosuppressive drugs;
* Known history of allergy to the formulation of Sintilimab or any other component of the antibody formulation;
* Patients with other malignant tumors.

Where this trial is running

Yichang, Hubei

• Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University — Yichang, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Xinhua Xu, Master

Conditions: Hepatocellular Carcinoma