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

NCT ID: NCT06029829

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2024-06-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy

Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy

Interventions

Sintilimab

Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xin-Hua Xu

OTHER

Sponsor Role: lead

Responsible Party

Xin-Hua Xu

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University

Yichang, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinhua Xu, Master

Role: CONTACT

2732774352@qq.com

13986747496 ext. 86

Siqi Liu, Postgr

Role: CONTACT

1301915712@qq.com

18272447628 ext. 86

Facility Contacts

Xinhua Xu

Role: primary

2732774352@qq.com

+8613986747496 ext. +8613986747496

Other Identifiers

CTGU008

Identifier Type: -

Identifier Source: org_study_id