Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma
NCT04996459 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40
Last updated 2021-08-09
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
Interventions
- DRUG
-
Tislelizumab
Tislelizumab 200mg iv q3w
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
Lu Wang, M.D. · FUSCC
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-01
- Primary Completion
- 2021-06-30
- Completion
- 2022-06-30
Countries
- China
Study Locations
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