Carcinoma, HepatocellularPhase 2NCT05366829
Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
A Phase 2 study testing Tislelizumab in people with Carcinoma, Hepatocellular and Liver Cell Carcinoma, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
The investigators hypothesize that the addition of Tislelizumab after definitive local therapy for locally advanced inoperable Hepatocellular carcinoma (HCC) will synergize with local therapy as well as treat micro metastatic disease and improve one year progression-free survival rates for participants and optimize… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Liver Cell Carcinoma
- What is being tested?
- Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jul 2022to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Each patient eligible to participate in this study must meet all the following criteria:
- Written informed consent
- Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted
- Hepatocellular carcinoma diagnosis by histologic findings and/or imaging criteria of LI-RADS 5
- Eastern Cooperative Oncology Group performance status score of 0-2
- Age>/=18 years
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- Child-Pugh class A liver function or B7, BCLC A-C or deemed not a candidate for surgery or liver transplantation
- No extrahepatic metastasis detected on CT chest with or without IV contrast, abdomen and pelvis with IV and oral contrast (triphasic-if feasible based on kidney function), or MRI abdomen/liver and chest CT.
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 6 months after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤ 7 days of first dose of study drug
- Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 6 months after the last dose of tislelizumab. Males must agree not to donate or bank sperm during treatment with tislelizumab and for > 6 months after treatment stop.
- Must have 1 target lesion measurable in 1 dimension according to RECIST 1.1.
- Demonstrate adequate bone marrow and organ function as defined below:
- Hematologic - Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin > 8.5 g/dL, Platelet count ≥ 75,000/mcL
- Renal - Serum creatinine OR calculated* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL/min for participants with creatinine levels > 1.5x institutional ULN
- Calculate serum creatinine clearance using the standard Cockcroft-Gault formula.
- Urine protein Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate < 1g of protein in 24 hours
- Hepatic - Serum total bilirubin ≤ 3 mg/dL , AST (SGOT) and ALT (SGPT) ≤ 5x ULN , Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN *This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.
Who cannot join
- <!-- -->
- Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields
- Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time
- Severe, active co-morbidity as per investigator
- More than five discrete intrahepatic parenchymal foci of definite HCC or left/right or main portal vein thrombus
- Direct tumor extension into the stomach, duodenum, small bowel or large bowel
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- Measurable common or main branch biliary duct involvement with HCC
- Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions).
- Note: benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm.
- Prior liver transplant
- HIV positive
- Immunodeficiency requiring chronic systemic therapy or that may relapse
- Participants who have received prior immunotherapy.
- Participants with clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control
- Note: Participants with ascites who require pharmacologic intervention (e.g. diuretics) to maintain symptomatic control and who have been on stable doses of diuretics for two months days prior to the first dose of study treatment are eligible.
- Participants with clinically meaningful encephalopathy
- Participants who have undergone prior solid organ or bone marrow transplant except for patients with prior renal transplant for whom dialysis may be employed in the event of graft rejection.
- Patients must have documented hepatitis virology status.
- Participants with active hepatitis B virus (HBV) infection must have a viral load < 500 IU/mL within 28 days prior to start of Tislelizumab and be on suppressive therapy (per local standard of care) for a minimum of fourteen days prior to start of study treatment and for the length of the study. b. Participants with co-infection with HBV and hepatitis C virus (HCV) are excluded.
- Participants with a history of HCV infection but with negative HCV RNA by PCR are considered non-infected with HCV and can enroll.
- Participants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible.
- Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible.
- Participants with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only are eligible provided: 1) rash covers < 10% of body surface area (BSA), disease is well controlled at baseline and requires only low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%).
- Any malignancy ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g. resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
- Treatment with a live, attenuated vaccine within four weeks prior to initiation of study treatment with Tislelizumab.
- Note: Seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug a. Note: Participants who are currently or have previously been on any of the following steroid regimens are not excluded: i. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) ii. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption iii. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non- autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)
- With uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before first dose of study drug
- With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
- With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
- Severe infections within 4 weeks before first dose of study drug, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Received therapeutic oral or intravenous antibiotics within two weeks before first dose of study drug
- Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug
- Any of the following cardiovascular risk factors:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug b. Pulmonary embolism ≤ 28 days before first dose of study drug c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug d. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) ≤ 6 months before first dose of study drug e .Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug
- Has received any herbal medicine used to control cancer within fourteen days of the first study drug administration
- Participants with toxicities (because of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities)
- Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study c conduct.
- Concurrent participation in another therapeutic clinical study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Salma Jabbour, MD, 732-253-3961, jabbousk@cinj.rutgers.edu
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10451
Nitin Ohri, MD, 516-672-2711, ohri.nitin@gmail.com
About this study
The investigators hypothesize that the addition of Tislelizumab after definitive local therapy for locally advanced inoperable Hepatocellular carcinoma (HCC) will synergize with local therapy as well as treat micro metastatic disease and improve one year progression-free survival rates for participants and optimize local control.
Read the detailed description
Primary Objective:
To determine if consolidation therapy with Tislelizumab following local therapy improves one year progression-free survival in patients with locally advanced, unresectable Hepatocellular carcinoma ( HCC). Progression-free survival (PFS) is defined as the time from first administration of Tislelizumab until the criteria for disease progression is met by response evaluation criteria in solid tumors (RECIST)1.1 or death as a result of any cause, whichever occurs first.
Secondary Objectives:
- To determine if consolidation therapy with Tislelizumab after definitive therapy improves time to metastatic disease and overall survival (OS) in subjects with localized, inoperable Hepatocellular carcinoma (HCC).
- To assess objective response rate, disease control rate, duration of response with consolidation therapy with Tislelizumab after local therapy in subjects with localized, inoperable Hepatocellular carcinoma (HCC).
- To assess the safety profile of Tislelizumab after definitive therapy.
- To assess biomarker response as measured by Alpha fetoprotein (AFP), should the patient's tumor produce AFP.
Exploratory objectives:
- To determine the association of the tumor molecular profile from next-generation sequencing (NGS), of the tissue prior to the initiation of therapy with the treatment response.
- To analyze Circulating tumor DNA (ct DNA) as a biomarker of response to therapy and early detection of disease progression.
- Conditions
- Carcinoma, Hepatocellular, Liver Cell Carcinoma
- Being tested
- Tislelizumab
- Keywords
- Liver-Directed Therapy, Tislelizumab, Hepatocellular Carcinoma
- 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 (also known as BGB A317) is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against programmed cell death protein-1 (PD-1) under clinical development for the treatment of several human malignancies. Tislelizumab consolidation therapy after radiation therapy can capitalize on the immunomodulatory effect of radiotherapy and improve tumor responses and patient outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab in conjunction with radiation therapy | Experimental | Participants will receive local therapy including TACE+ RT or Ablation (tumors with incomplete ablation) + RT or RT alone (for patients not eligible for TACE or Ablation) and will be screened for eligibility prior to enrollment.
Once eligibility has been confirmed, Tislelizumab will be started before radiation therapy and will continue after radiation therapy.
Participants who do not receive Tislelizumab for a total of two cycles will be replaced and interpreted for only toxicity analysis. Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by number of participants experiencing adverse events
Number of participants experiencing adverse events grade three or higher, as defined by Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). Severity is a measure of intensity (eg, grade of a specific AE, mild [Grade 1], moderate [Grade 2], severe [Grade 3], or life-threatening [Grade 4]), whereas seriousness is classified by the criteria based on the regulatory definitions. Seriousness serves as the guide for defining regulatory reporting obligations from the Investigator Sponsor to applicable regulatory authorities as described in CTCAE version 5.0.
Measured: 48 months
Secondary outcomes (1)
Response and progression will be evaluated in this trial using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee (v1.1).
Changes in only the largest diameter (uni dimensional measurement) of the tumor lesions are used in the RECIST criteria.
Measurable Disease:
Tumor lesions: Must be accurately measured in at least 1 dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:
- 10 mm by CT scan (irrespective of scanner type) and MRI (no less than double the slice thickness and a minimum of 10 mm)
- 10 mm caliper measurement by clinical exam (when superficial)
- 20 mm by chest X ray (if clearly defined and surrounded by aerated lung) Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be ≥ 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm). At baseline and in follow up, only the short axis will be measured and followed.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start25 Jul 2022
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Model description
- This study is a single-arm open-label phase II clinical trial to evaluate safety of the sequence of definitive therapy followed by Tislelizumab in participants with locally advanced unresectable hepatocellular carcinoma.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- BioGene Pharmaceutical Ltd., Natera, Inc.
- Responsible party
- Principal investigator, Salma Jabbour, MD, Rutgers, The State University of New Jersey
- Investigators
- Salma Jabbour, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366829
- Sponsor's protocol ID
- 072105
- Other IDs
- Pro2021001725
- Status last verified
- Jan 2026
- First submitted
- 4 May 2022
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05366829
- Acronym / sponsor ID
- 072105
- Conditions
- Carcinoma, Hepatocellular, Liver Cell Carcinoma
- Keywords
- Liver-Directed Therapy, Tislelizumab, Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- BioGene Pharmaceutical Ltd., Natera, Inc.
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 May 2022 (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.
The investigators hypothesize that the addition of Tislelizumab after definitive local therapy for locally advanced inoperable Hepatocellular carcinoma (HCC) will synergize with local therapy as well as treat micro metastatic disease and improve one year progression-free survival rates for participants and optimize local control.
Detailed description
Primary Objective:
To determine if consolidation therapy with Tislelizumab following local therapy improves one year progression-free survival in patients with locally advanced, unresectable Hepatocellular carcinoma ( HCC). Progression-free survival (PFS) is defined as the time from first administration of Tislelizumab until the criteria for disease progression is met by response evaluation criteria in solid tumors (RECIST)1.1 or death as a result of any cause, whichever occurs first.
Secondary Objectives:
- To determine if consolidation therapy with Tislelizumab after definitive therapy improves time to metastatic disease and overall survival (OS) in subjects with localized, inoperable Hepatocellular carcinoma (HCC).
- To assess objective response rate, disease control rate, duration of response with consolidation therapy with Tislelizumab after local therapy in subjects with localized, inoperable Hepatocellular carcinoma (HCC).
- To assess the safety profile of Tislelizumab after definitive therapy.
- To assess biomarker response as measured by Alpha fetoprotein (AFP), should the patient's tumor produce AFP.
Exploratory objectives:
- To determine the association of the tumor molecular profile from next-generation sequencing (NGS), of the tissue prior to the initiation of therapy with the treatment response.
- To analyze Circulating tumor DNA (ct DNA) as a biomarker of response to therapy and early detection of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single-arm open-label phase II clinical trial to evaluate safety of the sequence of definitive therapy followed by Tislelizumab in participants with locally advanced unresectable hepatocellular carcinoma.
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab in conjunction with radiation therapy | Experimental | Drug: TislelizumabParticipants will receive local therapy including TACE+ RT or Ablation (tumors with incomplete ablation) + RT or RT alone (for patients not eligible for TACE or Ablation) and will be screened for eligibility prior to enrollment. Once eligibility has been confirmed, Tislelizumab will be started before radiation therapy and will continue after radiation therapy. Participants who do not receive Tislelizumab for a total of two cycles will be replaced and interpreted for only toxicity analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Each patient eligible to participate in this study must meet all the following criteria:
- Urine protein Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate < 1g of protein in 24 hours
Key exclusion criteria (39 listed)
- <!-- -->
- Note: benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm.
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 (also known as BGB A317) is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against programmed cell death protein-1 (PD-1) under clinical development for the treatment of several human malignancies. Tislelizumab consolidation therapy after radiation therapy can capitalize on the immunomodulatory effect of radiotherapy and improve tumor responses and patient outcomes. | Drug | Tislelizumab in conjunction with radiation therapy |
Primary outcome
Safety as assessed by number of participants experiencing adverse events
Time frame: 48 months
Number of participants experiencing adverse events grade three or higher, as defined by Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). Severity is a measure of intensity (eg, grade of a specific AE, mild [Grade 1], moderate [Grade 2], severe [Grade 3], or life-threatening [Grade 4]), whereas seriousness is classified by the criteria based on the regulatory definitions. Seriousness serves as the guide for defining regulatory reporting obligations from the Investigator Sponsor to applicable regulatory authorities as described in CTCAE version 5.0.
1 secondary outcome
Response and progression will be evaluated in this trial using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee (v1.1).
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- 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.
Salma Jabbour, MD principal investigator
Rutgers Cancer Institute of New Jersey
2 sites 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 in people with Carcinoma, Hepatocellular and Liver Cell Carcinoma, run by Rutgers, The State University of New Jersey at 2 sites in United States.
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 17 inclusion and 39 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma Jabbour, MD (732-253-3961, jabbousk@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by number of participants experiencing adverse events (time frame: 48 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 20 Jan 2026.