Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT04996459
Status:
UNKNOWN
Last Update Posted:
2021-08-09
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
Real-world Study of Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study purpose: To evaluate the efficacy and safety of Tislelizumab in combination with advanced hepatocellular carcinoma in the real world; Study design: Non-intervention, single center, case registration, real-world study; Number of registrations: 40;
Source of data: This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:
1. Age ≥18 years old;
2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
3. Plan or have received systemic therapy combined with Tiralizumab;
4. No participation in other clinical studies;
5. Access to Tislelizumab treatment and other clinical records; Primary endpoint: Overall response rate; Secondary endpoint: Disease control rate, progress free survival, overall survival, safety; Exploratory endpoint: To explore the predictive value of multiple Biomarker combinations, such as PD-L1, TMB, MSI, DDR, POLE/POLD, in HCC immunotherapy response.
Source of data: This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:
1. Age ≥18 years old;
2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
3. Plan or have received systemic therapy combined with Tiralizumab;
4. No participation in other clinical studies;
5. Access to Tislelizumab treatment and other clinical records; Primary endpoint: Overall response rate; Secondary endpoint: Disease control rate, progress free survival, overall survival, safety; Exploratory endpoint: To explore the predictive value of multiple Biomarker combinations, such as PD-L1, TMB, MSI, DDR, POLE/POLD, in HCC immunotherapy response.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: