Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

Fudan University

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Tislelizumab

Study type: Observational

Funder types: Other

Identifiers

NCT04996459

GWK-2020-06

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

40 participants in 1 patient group

Tislelizumab group

Treatment:

Drug: Tislelizumab