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

NCT06029829 | Unknown Phase 2 DMC

• 1 other identifier: CTGU008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Study Arms (1)

Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy

EXPERIMENTAL

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

Drug: Sintilimab

Interventions

Sintilimab DRUG

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

Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xin-Hua Xu: lead

Study Sites (1)

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

Yichang, Hubei, 443003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Xinhua Xu, Master

CONTACT

13986747496; 2732774352@qq.com

Siqi Liu, Postgr

CONTACT

18272447628; 1301915712@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 8, 2023
• Study Start: January 12, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

CN (1)