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Recruiting NCT06241326

Immunotherapy for Hepatocellular Carcinoma

Observational Hepatocellular Carcinoma Immunotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immunotherapy-based Combination Therapies.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Immunotherapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • Adverse events [Time frame: 24 months]
Secondary outcome measures (5)
  • Progression free survival [Time frame: 24 months]
  • Disease control rate [Time frame: 24 months]
  • Objective response rate [Time frame: 24 months]
  • Duration of response [Time frame: 24 months]
  • Overall survival [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

China · 1 center
  • Jiangsu Province Hospital — Nanjing

Identifiers

NCT: NCT06241326 · 2023-SR-876

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗