Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Real-world Study of Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04996459
• Other study ID #: GWK-2020-06
• Status: Active, not recruiting
• Start date: March 1, 2020
• Est. completion date: June 2022

Study information

• Verified date: August 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Tislelizumab;

4. No participation in other clinical studies;

5. Access to Tislelizumab treatment and other clinical records.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Tislelizumab
Tislelizumab 200mg iv q3w

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate	overall response rate	6 weeks
Secondary	disease control rate	disease control rate	6 weeks
Secondary	progress free survival	progress free survival	6 weeks
Secondary	overall survival	overall survival	6 weeks
Secondary	Safety (the incidence of adverse events and serious adverse events)	the incidence of adverse events and serious adverse events	3 weeks