Back to resultsThe Clinical Significance of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution.
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
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.
Sites / Locations
- Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy
Arm Description
Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06029829
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xin-Hua Xu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy
Arm Type
Experimental
Arm Description
Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy
Primary Outcome Measure Information:
Title
Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinhua Xu, Master
Phone
13986747496
Ext
86
Email
2732774352@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Siqi Liu, Postgr
Phone
18272447628
Ext
86
Email
1301915712@qq.com
Facility Information:
Facility Name
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
City
Yichang
State/Province
Hubei
ZIP/Postal Code
443003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinhua Xu
Phone
+8613986747496
Ext
+8613986747496
Email
2732774352@qq.com
12. IPD Sharing Statement
Learn more about this trial
The Clinical Significance of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution.
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