Immunotherapy for Hepatocellular Carcinoma
IFHC
A Real-world Study of Immunotherapy-based Combination Therapies in Chinese Patients With Hepatocellular Carcinoma
1 other identifier
observational
11,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 10, 2024
April 1, 2024
2.8 years
January 28, 2024
April 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
All adverse events during the course of the study treatment.
24 months
Secondary Outcomes (5)
Progression free survival
24 months
Disease control rate
24 months
Objective response rate
24 months
Duration of response
24 months
Overall survival
24 months
Study Arms (2)
retrospective cohort
The patients in the retrospective cohort are hepatocellular carcinoma patients who have been previously treated with immunotherapy-based combination regimens. It is anticipated that approximately 10,000 cases will be included.
prospective cohort
The patients included in the prospective cohort are hepatocellular carcinoma patients who are being evaluated by researchers to determine the potential benefits of undergoing immunotherapy-based combination treatment regimens. It is anticipated that approximately 1,000 cases will be enrolled.
Interventions
immunotherapy-based combination therapies in Chinese HCC patients within the practical context of real-world conditions
Eligibility Criteria
Chinese hepatocellular carcinoma (HCC) patients
You may qualify if:
- 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.
You may not qualify if:
- Pregnant or lactating women.
- Other conditions regimented at investigators' discretion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2024
First Posted
February 5, 2024
Study Start
March 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 10, 2024
Record last verified: 2024-04