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New treatment option for Carcinoma, Hepatocellular
Official title Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT05366829
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, being studied as a potential treatment for carcinoma, hepatocellular.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
- Measurable common or main branch biliary duct involvement with HCC
See the full eligibility criteria
Who can 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
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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
- 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...
- 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 a. Note: Participants with ascites who require...
- 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. a. 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...
- 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...
- 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...
- 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...
- 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: a. 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...
- 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...
- 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...
- Concurrent participation in another therapeutic clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.