Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGTislelizumab
Tislelizumab 200mg iv q3w
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | 6 weeks | overall response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progress free survival | 6 weeks | progress free survival |
| overall survival | 6 weeks | overall survival |
| disease control rate | 6 weeks | disease control rate |
| Safety (the incidence of adverse events and serious adverse events) | 3 weeks | the incidence of adverse events and serious adverse events |
Countries
China
Outcome results
None listed