Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Tislelizumab

• Registration Number: NCT04996459
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-06-30
• Status Verified: 2021-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-05
• Last Update Submitted: 2021-08-05
• Study First Posted: 2021-08-09
• Last Update Posted: 2021-08-09
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tislelizumab group	Tislelizumab	-

Primary Outcome Measures

Name	Time	Method
overall response rate	6 weeks	overall response rate

Secondary Outcome Measures

Name	Time	Method
overall survival	6 weeks	overall survival
Safety (the incidence of adverse events and serious adverse events)	3 weeks	the incidence of adverse events and serious adverse events
disease control rate	6 weeks	disease control rate
progress free survival	6 weeks	progress free survival

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China