Immunotherapy for Hepatocellular Carcinoma

NCT ID: NCT06241326

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

11000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-12-31

Brief Summary

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This study is an observational real-world research conducted on Chinese hepatocellular carcinoma (HCC) patients. Its primary objective is to evaluate the safety and efficacy of immunotherapy-based combination therapies in Chinese HCC patients within the practical context of real-world conditions.

Detailed Description

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Hepatocellular carcinoma exhibits a significantly elevated incidence and mortality rate in China. Despite the Chinese population representing a mere 18.4% of the global population, the annual incidence of new liver cancer cases reaches a staggering 466,000 (55.4% of the global total), with 422,000 deaths (53.9% of the global total). Immunotherapy, particularly the implementation of immunotherapy-based combination treatment regimens, holds substantial therapeutic value in the management of hepatocellular carcinoma (HCC), leading to notable breakthroughs and advancements in the comprehensive treatment of liver cancer. The aim of this study is to evaluate the safety and efficacy of immunotherapy-based combination treatment regimens in Chinese hepatocellular carcinoma (HCC) patients under real-world clinical conditions. By collecting and analyzing data on the etiology, clinical characteristics, treatment modalities, and treatment outcomes of HCC patients receiving immunotherapy-based combination treatments in the clinical healthcare setting, the study seeks to provide valuable information regarding treatment patterns and effectiveness for hepatocellular carcinoma patients.

Conditions

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Hepatocellular Carcinoma Immunotherapy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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retrospective cohort

The patients in the retrospective cohort are hepatocellular carcinoma patients who have been previously treated with immunotherapy-based combination regimens. It is anticipated that approximately 10,000 cases will be included.

Immunotherapy-based Combination Therapies

Intervention Type OTHER

immunotherapy-based combination therapies in Chinese HCC patients within the practical context of real-world conditions

prospective cohort

The patients included in the prospective cohort are hepatocellular carcinoma patients who are being evaluated by researchers to determine the potential benefits of undergoing immunotherapy-based combination treatment regimens. It is anticipated that approximately 1,000 cases will be enrolled.

Immunotherapy-based Combination Therapies

Intervention Type OTHER

immunotherapy-based combination therapies in Chinese HCC patients within the practical context of real-world conditions

Interventions

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Immunotherapy-based Combination Therapies

immunotherapy-based combination therapies in Chinese HCC patients within the practical context of real-world conditions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Aged after 18 years (18 is included).
2. Hepatocellular carcinoma diagnosed by pathology or imaging.
3. Patients assessed by researchers as potentially benefiting from receiving immunotherapy-based combination regimens.
4. For participants who have previously received treatment according to this protocol, a comprehensive pre-treatment assessment is required, including demographic information, tumor history, medical history, and baseline imaging examinations.
5. Patients voluntarily enroll in this study.

Exclusion Criteria

1. Pregnant or lactating women.
2. Other conditions regimented at investigators' discretion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuehao Wang, professor

Role: CONTACT

86-025-68303211

Yongxiang Xia, professor

Role: CONTACT

86-025-68303211

Facility Contacts

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Xuehao Wang

Role: primary

86-025-68303211

Other Identifiers

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2023-SR-876

Identifier Type: -

Identifier Source: org_study_id

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