BCLC Stage C Hepatocellular CarcinomaPhase 2NCT04992143
TACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC
A Phase 2 study testing TACE, Tilelizumab and Sorafenib in people with BCLC Stage C Hepatocellular Carcinoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BCLC Stage C Hepatocellular Carcinoma
- What is being tested?
- TACE, Tilelizumab and Sorafenib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2021to 30 Dec 2023
- Phase
- Phase 2
- 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
Who may be able to join
- Age ≥18 years
- Child-Pugh score≤ 7
- HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2019
- the primary HCC being in BCLC C stage according to NCCN guideline
- No previous systemic therapy for HCC
Who cannot join
- Diffuse HCC
- Uncontrolled ascites of hepatic encephalopathy
- Prior liver transplantation
- Positive for human immunodeficiency virus
- Active gastric or duodenal ulcer
- Other uncontrolled comorbidities or malignancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Jun-hui Sun, MD,PH.D, +86-0571-87236815, 1307005@zju.edu.cn
Tong-yin Zhu, MD, +86-0571-87236812, 1513001@zju.edu.cn
About this study
Official title: The Efficacy and Safety of TACE Combined With Tilelizumab and Sorafenib in Treating BCLC Stage C HCC Patients: a Single-center, Single-arm, Prospective Clinical Study
According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.
- Conditions
- BCLC Stage C Hepatocellular Carcinoma
- Keywords
- BCLC Stage C, Hepatocellular Carcinoma, Transarterial Chemoembolization, Sorafenib, Tilelizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
TACE first ,and more TACE could be performed when it is necessary.
TilelizumabDrug
Tilelizumab 240mg per 3weeks ivgtt within 1 week after the first TACE
SorafenibDrug
Sorafenib should be administered 400 mg twice /day orally within 1 week after the first TACE
| Study group | Role | What they receive |
|---|---|---|
| TACE combined Tilelizumab and Sorafenib | Experimental | TACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally) Receives: Procedure: TACE; Drug: Tilelizumab; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year survival rate
1-year survival rate assessed by Kaplan-Meier analysis
Measured: at 1 year after enrolled
Secondary outcomes (4)
Time to progression
Time to progression assessed by independent radiologic review according to mRECIST criteria
Measured: at 12 weeks and up to 2 years after enrolled
Progression free survival
Progression free survival assessed by independent radiologic review according to mRECIST criteria
Measured: at 12 weeks and up to 2 years after enrolled
Objective response rate
Objective response rate assessed by independent radiologic review according to mRECIST criteria
Measured: at 12 weeks and up to 2 years after enrolled
Disease control rate
Disease control rate assessed by independent radiologic review according to mRECIST criteria
Measured: at 12 weeks and up to 2 years after enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start20 Aug 2021
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCLC Stage C Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun-hui Sun, MD,PH.D, Study director, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992143
- Sponsor's protocol ID
- HEPIC2004
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of TACE Combined With Tilelizumab and Sorafenib in Treating BCLC Stage C HCC Patients: a Single-center, Single-arm, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04992143
- Acronym / sponsor ID
- HEPIC2004
- Conditions
- BCLC Stage C Hepatocellular Carcinoma
- Keywords
- BCLC Stage C, Hepatocellular Carcinoma, Transarterial Chemoembolization, Sorafenib, Tilelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 5 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.
According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE combined Tilelizumab and Sorafenib | Experimental | Procedure: TACE, Drug: Tilelizumab, Drug: SorafenibTACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Child-Pugh score≤ 7
- HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2019
- the primary HCC being in BCLC C stage according to NCCN guideline
- No previous systemic therapy for HCC
Key exclusion criteria (6 listed)
- Diffuse HCC
- Uncontrolled ascites of hepatic encephalopathy
- Prior liver transplantation
- Positive for human immunodeficiency virus
- Active gastric or duodenal ulcer
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 |
|---|---|---|
| TACETACE first ,and more TACE could be performed when it is necessary. | Procedure or surgery | TACE combined Tilelizumab and Sorafenib |
| TilelizumabTilelizumab 240mg per 3weeks ivgtt within 1 week after the first TACE | Drug | TACE combined Tilelizumab and Sorafenib |
| SorafenibSorafenib should be administered 400 mg twice /day orally within 1 week after the first TACE | Drug | TACE combined Tilelizumab and Sorafenib |
Primary outcome
1-year survival rate
Time frame: at 1 year after enrolled
1-year survival rate assessed by Kaplan-Meier analysis
4 secondary outcomes
Time to progression
Time frame: at 12 weeks and up to 2 years after enrolled
Progression free survival
Time frame: at 12 weeks and up to 2 years after enrolled
Objective response rate
Time frame: at 12 weeks and up to 2 years after enrolled
Disease control rate
Time frame: at 12 weeks and up to 2 years after enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Jun-hui Sun, MD,PH.D study director
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TACE, Tilelizumab and Sorafenib in people with BCLC Stage C Hepatocellular Carcinoma, run by First Affiliated Hospital of Zhejiang 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?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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 16 Feb 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jun-hui Sun, MD,PH.D (+86-0571-87236815, 1307005@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year survival rate (time frame: at 1 year after enrolled). 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 16 Feb 2023.