Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

NCT ID: NCT04996459

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-06-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tislelizumab group

Tislelizumab

Intervention Type: DRUG

Tislelizumab 200mg iv q3w

Interventions

Tislelizumab

Tislelizumab 200mg iv q3w

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Lu Wang, MD, PhD

Head of liver surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lu Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

FUSCC

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Countries

China

Other Identifiers

GWK-2020-06

Identifier Type: -

Identifier Source: org_study_id