Immunotherapy for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— IFHC  

Official title:

A Real-world Study of Immunotherapy-based Combination Therapies in Chinese Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241326
• Other study ID #: 2023-SR-876
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Xuehao Wang, professor
• Phone: 86-025-68303211
• Email: mxrlwx19911990[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Immunotherapy

Intervention

Other:
• Immunotherapy-based Combination Therapies
immunotherapy-based combination therapies in Chinese HCC patients within the practical context of real-world conditions

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	All adverse events during the course of the study treatment.	24 months
Secondary	Progression free survival	From date of admission until the date of first documented progression in the real-world setting or date of death from any cause, whichever came first, assessed up to 24 months.	24 months
Secondary	Disease control rate	The percentage of subjects achieving complete response, partial response, or disease stability in a real-world clinical setting.	24 months
Secondary	Objective response rate	The percentage of subjects achieving complete or partial response in a real-world clinical setting.	24 months
Secondary	Duration of response	The time from the first documentation of objective response to the first assessment of progression in the real-world setting.	24 months
Secondary	Overall survival	From date of admission until the date of death from any cause, assessed up to 24 months.	24 months