Hepatocellular CarcinomaNCT04996459
Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to Jun 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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:
- Age ≥18 years old;
- Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
- Plan or have received systemic therapy combined with Tislelizumab;
- No participation in other clinical studies;
- Access to Tislelizumab treatment and other clinical records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Age ≥18 years old;
- Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
- Plan or have received systemic therapy combined with Tiralizumab;
- No participation in other clinical studies;
- 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
- Being tested
- Tislelizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab 200mg iv q3w
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab group | Not described Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
overall response rate
Measured: 6 weeks
Secondary outcomes (4)
disease control rate
disease control rate
Measured: 6 weeks
progress free survival
progress free survival
Measured: 6 weeks
overall survival
overall survival
Measured: 6 weeks
Safety (the incidence of adverse events and serious adverse events)
the incidence of adverse events and serious adverse events
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Mar 2020
- Primary completion30 Jun 2021
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
- Investigators
- Lu Wang, M.D., Principal investigator, FUSCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996459
- Sponsor's protocol ID
- GWK-2020-06
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04996459
- Acronym / sponsor ID
- GWK-2020-06
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Age ≥18 years old;
- Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
- Plan or have received systemic therapy combined with Tiralizumab;
- No participation in other clinical studies;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab group | – | Drug: Tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabTislelizumab 200mg iv q3w | Drug | Tislelizumab group |
Primary outcome
overall response rate
Time frame: 6 weeks
overall response rate
4 secondary outcomes
disease control rate
Time frame: 6 weeks
progress free survival
Time frame: 6 weeks
overall survival
Time frame: 6 weeks
Safety (the incidence of adverse events and serious adverse events)
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Wang, M.D. principal investigator
FUSCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.