Clinical trial NCT06029829: The Clinical Significance of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution.
Official title: The Clinical Value of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution in the Immunotherapy of Advanced Primary HCC Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: China Three Gorges University, Yichang, China
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Providing more theoretical basis for the prediction of the efficacy of advanced HCC and helping select better advantaged population of HCC immunotherapy to maximize the benefits of patients By exploring the relationship between the changes of PD-1 expression in peripheral blood T lymphocytes and the clinical efficacy before and after the use of PD-1 / PD-L1 inhibitors.

Detailed description: Exploring the expression of peripheral blood T lymphocyte PD-1 from an immunological perspective as a potential reference marker for selecting immunotherapy in advanced HCC patients, and elucidating the relationship between the level of peripheral blood T lymphocyte PD-1 expression and survival outcomes after receiving immunotherapy. Additionally, investigating whether there is consistency between the expression levels of PD-1 and PD-L1 and their impact on patients. Furthermore, exploring the correlation between the distribution of T cell subsets and the efficacy of immunotherapy to provide new theoretical evidence for the selection of target populations for immunotherapy and new clinical screening indicators for patient prognosis assessment.

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.

Primary outcomes:
measure: Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yichang
country: China
facility: Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
state: Hubei
Study officials:
References: