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

Sponsor

Xin-Hua Xu (Other)

Overall Status

Recruiting

CT.gov ID

NCT06029829

Collaborator

(none)

Enrollment

Location

Arm

17.6

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Sintilimab	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jan 12, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy	Drug: Sintilimab Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy

Arm

Intervention/Treatment

Experimental: Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy

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

Drug: Sintilimab

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

Outcome Measures

Primary Outcome Measures

Compare Progression Free Survival (PFS) Regimen using RECIST 1.1. [24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University	Yichang	Hubei	China	443003

Sponsors and Collaborators

Xin-Hua Xu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xin-Hua Xu, professor, China Three Gorges University, Yichang, China

ClinicalTrials.gov Identifier:

NCT06029829

Other Study ID Numbers:

CTGU008

First Posted:

Sep 8, 2023

Last Update Posted:

Sep 8, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Sep 8, 2023