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

September 1, 2023 updated by: Xin-Hua Xu

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Yichang, Hubei, China, 443003
        • Recruiting
        • Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xin-Hua Xu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 26, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTGU008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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