Is NCT05366829 recruiting in New Brunswick, NJ?

Yes, NCT05366829 is currently recruiting participants at its New Brunswick, NJ location. This hepatocellular carcinoma clinical trial is actively enrolling qualified participants.

How do I join the hepatocellular carcinoma clinical trial in New Brunswick?

To join this clinical trial in New Brunswick, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New Brunswick clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Hepatocellular Carcinoma Clinical Trial in New Brunswick, NJ

About This Hepatocellular Carcinoma Study in New Brunswick

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.

Sponsor: Rutgers, The State University of New Jersey

Who Can Participate

Inclusion Criteria

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 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.

Exclusion Criteria

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 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 a. 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. 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 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. c. 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: 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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Brunswick?

Yes, this clinical trial (NCT05366829) has an active research site in New Brunswick, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hepatocellular Carcinoma Treatment Options in New Brunswick, NJ

If you're searching for hepatocellular carcinoma treatment options in New Brunswick, NJ, this clinical trial (NCT05366829) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Brunswick research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced hepatocellular carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hepatocellular carcinoma clinical trials near you to find additional studies recruiting in your area.

Hepatocellular Carcinoma Clinical Trial in New Brunswick, NJ

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