Status:
UNKNOWN
The Clinical Significance of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution.
Lead Sponsor:
Xin-Hua Xu
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 explori...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06029829
Start Date
January 12 2023
End Date
June 30 2024
Last Update
September 8 2023
Active Locations (1)
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1
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Yichang, Hubei, China, 443003