Liver NeoplasmsPhase 2NCT06059885
Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC
A Phase 2 study testing Tislelizumab plus tyrosine kinase inhibitor in people with Liver Neoplasms, run by Beijing 302 Hospital at 1 site in China.
Trial summary
Background: Ablation is important radical treatment in hepatocellular carcinoma (HCC). However, the 5-year recurrence rate of HCC after ablation is up to 80%. Early and late recurrences are more likely related to tumor size, tumor multiplicity, vascular invasion, higher serum AFP level and disease etiology, etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Tislelizumab plus tyrosine kinase inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2021to 20 Dec 2025
- 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
- Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology or cytology, with no prior targeted or immune checkpoint therapy for HCC, and have undergone curative ablation with no residual lesions according to imaging or pathological assessment. Patients are at high risk of recurrence meeting one of the following criteria:
- solitary tumor >2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm； poor tumor differentiation； macrovascular invasion of the portal vein(Vp1/Vp2) ； the absence or infiltration of a tumor capsule ； AFP≥32ng/ml； HBV DNA ≥105IU/ml； history of recurrence after curative treatment； family history of tumors.
Who cannot join
- Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
302 Hospital
Beijing, Beijing Municipality, 100039
Fanping Meng, drmengfanping@126.com
About this study
Official title: Tislelizumab Plus Tyrosine Kinase Inhibitor (TKI) as Adjuvant Therapy Versus Active Surveillance in Patients With HCC at High Risk of Recurrence After Curative Ablation: A Prospective Cohort Study
Background: Ablation is important radical treatment in hepatocellular carcinoma (HCC). However, the 5-year recurrence rate of HCC after ablation is up to 80%. Early and late recurrences are more likely related to tumor size, tumor multiplicity, vascular invasion, higher serum AFP level and disease etiology, etc. Some studies suggested that adjuvant immunotherapy might be associated with decreased recurrence and prolonged RFS. Adjuvant atezolizumab + bevacizumab (IMbrave 050) showed RFS improvement following curative resection or ablation. Currently, there is limited study on immunotherapy combined with TKI as postoperative adjuvant therapy for HCC. This is an open-label, prospective cohort study to compare the efficacy and safety of tislelizumab plus tyrosine kinase inhibitor (TKI) as adjuvant therapy versus active surveillance in HCC patients with high risk of recurrence after curative ablation.
- Conditions
- Liver Neoplasms
- Being tested
- Tislelizumab plus tyrosine kinase inhibitor
- Keywords
- HCC, Liver Cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab plus tyrosine kinase inhibitorDrug
Lenvatinib, tyrosine kinase inhibitor (TKIs)
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with tyrosine kinase inhibitor (TKI) treatment group | Experimental | Not described Receives: Drug: Tislelizumab plus tyrosine kinase inhibitor |
| No-intervention group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor recurrence rate (DRR)
Thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed before radical treatment, thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed after adjuvant treatment, and then thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed every 12 weeks. Tumor changes were evaluated by imaging. In addition, we will evaluate adverse events and death events: classify and grade adverse events, record the time and cause of death of patients. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start22 Dec 2021
- Primary completion31 Mar 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanping Meng, Beijing 302 Hospital
- Investigators
- Fanping Meng, Principal investigator, 302 Hospital Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059885
- Sponsor's protocol ID
- ChiECRCT20210555
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 29 Sep 2023
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Plus Tyrosine Kinase Inhibitor (TKI) as Adjuvant Therapy Versus Active Surveillance in Patients With HCC at High Risk of Recurrence After Curative Ablation: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06059885
- Acronym / sponsor ID
- ChiECRCT20210555
- Conditions
- Liver Neoplasms
- Keywords
- HCC, Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 29 Sep 2023 (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.
Background: Ablation is important radical treatment in hepatocellular carcinoma (HCC). However, the 5-year recurrence rate of HCC after ablation is up to 80%. Early and late recurrences are more likely related to tumor size, tumor multiplicity, vascular invasion, higher serum AFP level and disease etiology, etc. Some studies suggested that adjuvant immunotherapy might be associated with decreased recurrence and prolonged RFS. Adjuvant atezolizumab + bevacizumab (IMbrave 050) showed RFS improvement following curative resection or ablation. Currently, there is limited study on immunotherapy combined with TKI as postoperative adjuvant therapy for HCC. This is an open-label, prospective cohort study to compare the efficacy and safety of tislelizumab plus tyrosine kinase inhibitor (TKI) as adjuvant therapy versus active surveillance in HCC patients with high risk of recurrence after curative ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with tyrosine kinase inhibitor (TKI) treatment group | Experimental | Drug: Tislelizumab plus tyrosine kinase inhibitor |
| No-intervention group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology or cytology, with no prior targeted or immune checkpoint therapy for HCC, and have undergone curative ablation with no residual lesions according to imaging or pathological assessment. Patients are at high risk of recurrence meeting one of the following criteria:
- solitary tumor >2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm； poor tumor differentiation； macrovascular invasion of the portal vein(Vp1/Vp2) ； the absence or infiltration of a tumor capsule ； AFP≥32ng/ml； HBV DNA ≥105IU/ml； history of recurrence after curative treatment； family history of tumors.
Key exclusion criteria (1 listed)
- Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;
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 |
|---|---|---|
| Tislelizumab plus tyrosine kinase inhibitorLenvatinib, tyrosine kinase inhibitor (TKIs) | Drug | Tislelizumab combined with tyrosine kinase inhibitor (TKI) treatment group |
Primary outcome
Tumor recurrence rate (DRR)
Time frame: 52 weeks
Thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed before radical treatment, thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed after adjuvant treatment, and then thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed every 12 weeks. Tumor changes were evaluated by imaging. In addition, we will evaluate adverse events and death events: classify and grade adverse events, record the time and cause of death of patients. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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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.
Fanping Meng principal investigator
302 Hospital Beijing, China
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 plus tyrosine kinase inhibitor in people with Liver Neoplasms, run by Beijing 302 Hospital 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 2 inclusion and 1 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 29 Sep 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 Fanping Meng (010-66933219, drmengfanping@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor recurrence rate (DRR) (time frame: 52 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 29 Sep 2023.