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Immunotherapy for Hepatocellular Carcinoma

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06241326
Acronym
IFHC
Enrollment
11000
Registered
2024-02-05
Start date
2024-03-01
Completion date
2026-12-31
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Immunotherapy

Brief 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.

Detailed 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.

Interventions

OTHERImmunotherapy-based Combination Therapies

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

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Adverse events24 monthsAll adverse events during the course of the study treatment.

Secondary

MeasureTime frameDescription
Progression free survival24 monthsFrom 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.
Disease control rate24 monthsThe percentage of subjects achieving complete response, partial response, or disease stability in a real-world clinical setting.
Objective response rate24 monthsThe percentage of subjects achieving complete or partial response in a real-world clinical setting.
Duration of response24 monthsThe time from the first documentation of objective response to the first assessment of progression in the real-world setting.
Overall survival24 monthsFrom date of admission until the date of death from any cause, assessed up to 24 months.

Countries

China

Contacts

Primary ContactXuehao Wang, professor
mxrlwx19911990@163.com86-025-68303211
Backup ContactYongxiang Xia, professor
mxrlwx19911990@163.com86-025-68303211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026