The Clinical Significance of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution.

Hepatocellular Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029829
• Other study ID #: CTGU008
• Status: Recruiting
• Phase: Phase 2
• Start date: January 12, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: China Three Gorges University, Yichang, China
• Contact: Xinhua Xu, Master
• Phone: 13986747496
• Email: 2732774352[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sintilimab
Any first-line treatment that includes immunotherapy? Chemotherapy and Anti-angiogenesis Therapy

Locations

Country	Name	City	State
China	Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University	Yichang	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xin-Hua Xu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.	PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.	24 months