Hepatocellular CarcinomaPhase 2NCT04981665
A Study to Evaluate TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection
A Phase 2 study testing Tislelizumab and TACE in people with Hepatocellular Carcinoma and Adjuvant Therapy, run by Zhejiang University at 1 site in China.
Trial summary
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Adjuvant Therapy
- What is being tested?
- Tislelizumab and TACE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2021to Dec 2024
- 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
- Subjects with a histopathological or cytologically diagnosis of HCC
- Subjects who have undergone a curative resection
- High risk for HCC recurrence as protocol defined
- No previous systematic treatment and locoregional therapy for HCC
- Child-Pugh Score, Class A
- ECOG performance status 0 or 1
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- Full recovery from surgical resection
- Adequate organ function
- Absence of major macrovascular invasion
- No extrahepatic spread
- Life expectancy of at least 6 months
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of residual, recurrent, or metastatic disease
- Known history of serious allergy to any monoclonal antibody
- History of hepatic encephalopathy
- Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein
- Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment
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- Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
- Any active malignancy within 2 years prior to the start of treatment
- Active or history of autoimmune disease
- Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: Official Title ICMJE A Phase 2, Open-Label, Multi-Center, Single Arm Study to Evaluate the Efficacy and Safety of TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
Read the detailed description
Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring.
Until now there is no standard postoperative adjuvant therapy. Previous studies have shown that TACE combined with PD-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.
- Conditions
- Hepatocellular Carcinoma, Adjuvant Therapy
- Being tested
- Tislelizumab, TACE
- Keywords
- Hepatocellular carcinoma, Immunotherapy, Transarterial chemoembolization, Recurrence, Antineoplastic Agents, Immunological, Antineoplastic Agents
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317, Immunotherapy, Anti-PD-1 therapy
Tislelizumab 200mg IV Q3W
TACEDrug
Also called Transarterial Chemoembolization
TACE will be performed after curative resection (4±1w)
| Study group | Role | What they receive |
|---|---|---|
| Postoperative TACE + Tislelizumab 200mg IV Q3W | Experimental | TACE will be performed after curative resection (4±1w) once and then Tislelizumab Injection will be initiated after TACE (5±2d). Tislelizumab will be administered every three weeks, until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab. Receives: Drug: Tislelizumab; Drug: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Recurrence Free Survival Rate (2-year RFS rate)
2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.
Measured: Observation period 24 months
Secondary outcomes (6)
Recurrence-Free Survival (RFS)
RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first.
Measured: 24 months
Time to recurrence (TTR)
TTR is defined as the time from the date of curative resection to the first documented recurrence.
Measured: 24 months
Overall Survival (OS）
OS is defined as the time from the date of curative resection until death due to any cause.
Measured: 24 months
1-year RFS rate
1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 years after curative resection.
Measured: 12 months
1-year OS rate/2-year OS rate
OS rate is defined as the proportion of patients who have not experienced death from any cause at 12 and 24 months after curative resection.
Measured: 12 months/24 months
Adverse Events (AEs)
The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start8 Nov 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, Shandong Cancer Hospital and Institute, The Affiliated Hospital Of Southwest Medical University, Hainan People's Hospital, Tianjin Third Central Hospital
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981665
- Sponsor's protocol ID
- BGB-A317-2008
- Status last verified
- Jan 2022
- First submitted
- 25 Jul 2021
- Last updated
- 5 Jan 2022
- 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 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title ICMJE A Phase 2, Open-Label, Multi-Center, Single Arm Study to Evaluate the Efficacy and Safety of TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection
- ClinicalTrials.gov ID
- NCT04981665
- Acronym / sponsor ID
- BGB-A317-2008
- Conditions
- Hepatocellular Carcinoma, Adjuvant Therapy
- Keywords
- Hepatocellular carcinoma, Immunotherapy, Transarterial chemoembolization, Recurrence, Antineoplastic Agents, Immunological, Antineoplastic Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, Shandong Cancer Hospital and Institute, The Affiliated Hospital Of Southwest Medical University, Hainan People's Hospital, Tianjin Third Central Hospital
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Jul 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.
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
Detailed description
Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring.
Until now there is no standard postoperative adjuvant therapy. Previous studies have shown that TACE combined with PD-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative TACE + Tislelizumab 200mg IV Q3W | Experimental | Drug: Tislelizumab, Drug: TACETACE will be performed after curative resection (4±1w) once and then Tislelizumab Injection will be initiated after TACE (5±2d). Tislelizumab will be administered every three weeks, until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects with a histopathological or cytologically diagnosis of HCC
- Subjects who have undergone a curative resection
- High risk for HCC recurrence as protocol defined
- No previous systematic treatment and locoregional therapy for HCC
- Child-Pugh Score, Class A
Key exclusion criteria (12 listed)
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of residual, recurrent, or metastatic disease
- Known history of serious allergy to any monoclonal antibody
- History of hepatic encephalopathy
- Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein
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 |
|---|---|---|
| TislelizumabAlso: BGB-A317, Immunotherapy, Anti-PD-1 therapyTislelizumab 200mg IV Q3W | Drug | Postoperative TACE + Tislelizumab 200mg IV Q3W |
| TACEAlso: Transarterial ChemoembolizationTACE will be performed after curative resection (4±1w) | Drug | Postoperative TACE + Tislelizumab 200mg IV Q3W |
Primary outcome
2-year Recurrence Free Survival Rate (2-year RFS rate)
Time frame: Observation period 24 months
2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.
6 secondary outcomes
Recurrence-Free Survival (RFS)
Time frame: 24 months
Time to recurrence (TTR)
Time frame: 24 months
Overall Survival (OS）
Time frame: 24 months
1-year RFS rate
Time frame: 12 months
1-year OS rate/2-year OS rate
Time frame: 12 months/24 months
Adverse Events (AEs)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- 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.
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 Tislelizumab and TACE in people with Hepatocellular Carcinoma and Adjuvant Therapy, run by 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 11 inclusion and 12 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 5 Jan 2022. 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 Tingbo Liang (+8613666676128, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Recurrence Free Survival Rate (2-year RFS rate) (time frame: Observation period 24 months). 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 5 Jan 2022.