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Trial Title:
Immunotherapy for Hepatocellular Carcinoma
NCT ID:
NCT06241326
Condition:
Hepatocellular Carcinoma
Immunotherapy
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Immunomodulating Agents
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Immunotherapy-based Combination Therapies
Description:
immunotherapy-based combination therapies in Chinese HCC patients within the practical
context of real-world conditions
Arm group label:
prospective cohort
Arm group label:
retrospective cohort
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.
Criteria for eligibility:
Study pop:
Chinese hepatocellular carcinoma (HCC) patients
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuehao Wang
Phone:
86-025-68303211
Email:
wangxh@njmu.edu.cn
Start date:
March 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06241326
