Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

August 5, 2021 updated by: Lu Wang, MD, PhD, Fudan University

Real-world Study of Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients registrated and treated with Tislelizumab at least once were included in the efficacy analysis population as well as the safety analysis population.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tislelizumab group
Drug: Tislelizumab
Tislelizumab 200mg iv q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: 6 weeks
overall response rate
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease control rate
Time Frame: 6 weeks
disease control rate
6 weeks
progress free survival
Time Frame: 6 weeks
progress free survival
6 weeks
overall survival
Time Frame: 6 weeks
overall survival
6 weeks
Safety (the incidence of adverse events and serious adverse events)
Time Frame: 3 weeks
the incidence of adverse events and serious adverse events
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Lu Wang, M.D., FUSCC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GWK-2020-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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