Immunotherapy for Hepatocellular Carcinoma (IFHC)

Nanjing Medical University

Status: Enrolling

Conditions: Immunotherapy; Hepatocellular Carcinoma

Treatments: Other: Immunotherapy-based Combination Therapies

Study type: Observational

Funder types: Other

Identifiers

NCT06241326

2023-SR-876

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 11,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

11,000 participants in 2 patient groups

retrospective cohort

Description:

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.

Treatment:

Other: Immunotherapy-based Combination Therapies

prospective cohort

Description:

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.

Treatment:

Other: Immunotherapy-based Combination Therapies