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NCT Number: NCT06241326

Immunotherapy for Hepatocellular Carcinoma

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged after 18 years (18 is included).
  • Hepatocellular carcinoma diagnosed by pathology or imaging.
  • Patients assessed by researchers as potentially benefiting from receiving immunotherapy-based combination regimens.
  • 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.
  • Patients voluntarily enroll in this study.

Exclusion criteria

  • Pregnant or lactating women.
  • Other conditions regimented at investigators' discretion.

Treatment and study plan

Immunotherapy-based Combination Therapies

Other

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

Primary outcomes

  1. Adverse events

    Time frame: 24 months

    All adverse events during the course of the study treatment.

Secondary outcomes

  1. Progression free survival

    Time frame: 24 months

    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.

  2. Disease control rate

    Time frame: 24 months

    The percentage of subjects achieving complete response, partial response, or disease stability in a real-world clinical setting.

  3. Objective response rate

    Time frame: 24 months

    The percentage of subjects achieving complete or partial response in a real-world clinical setting.

  4. Duration of response

    Time frame: 24 months

    The time from the first documentation of objective response to the first assessment of progression in the real-world setting.

  5. Overall survival

    Time frame: 24 months

    From date of admission until the date of death from any cause, assessed up to 24 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Xuehao Wang, professor

CONTACT

[email protected]

86-025-68303211

Yongxiang Xia, professor

CONTACT

[email protected]

86-025-68303211

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: IFHC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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