Clinical trial NCT06241326: Immunotherapy for Hepatocellular Carcinoma
Official title: A Real-world Study of Immunotherapy-based Combination Therapies in Chinese Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Immunotherapy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 11000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese hepatocellular carcinoma (HCC) patients

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.

Eligibility 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.

Primary outcomes:
measure: Adverse events
timeFrame: 24 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 24 months
measure: Disease control rate
timeFrame: 24 months
measure: Objective response rate
timeFrame: 24 months
measure: Duration of response
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
References: