BridgeMD
New treatment option for Hepatocellular Carcinoma (HCC)
Official title Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer
ClinicalTrials.gov ID: NCT07075120
What this study is testing
What is Ipilimumab and Nivolumab?
Ipilimumab and Nivolumab is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma (hcc).
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
- Hepatocellular carcinoma (HCC) is a major cause of cancer-related deaths globally, with Native Hawaiian and Pacific Islander (NHPI) populations experiencing significantly higher mortality rates compared to other groups in Hawaii. This disparity is influenced by factors such as higher prevalence of chronic hepatitis B, non-alcoholic fatty liver disease, limited access to early detection, and delayed diagnoses.
- Phase 1: an early, usually small safety study
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
- Main Criteria for Inclusion/Exclusion
- Histologically or cytologically confirmed hepatocellular cancer
- Locally advanced/borderline resectable HCC as defined by:
- Solitary tumor \>5 cm, OR
- Unilobar multifocal disease either with \>3 tumors or one tumor \>3 cm, OR
You likely can't join if
- Prior systemic therapy for hepatocellular carcinoma
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s).
- Ascites that requires ongoing paracentesis, within 6 weeks prior to the first scheduled dose, to control symptoms.
- Active or prior documented GI variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 60 days prior to...
- Hepatic encephalopathy within 12 months of trial registration
- Patient currently exhibits symptomatic or uncontrolled hypertension defined as diastolic blood pressure \>90 mmHg or systolic blood pressure \>140...
See the full eligibility criteria
- Main Criteria for Inclusion/Exclusion
- Histologically or cytologically confirmed hepatocellular cancer
- Locally advanced/borderline resectable HCC as defined by:
- Solitary tumor \>5 cm, OR
- Unilobar multifocal disease either with \>3 tumors or one tumor \>3 cm, OR
- Bilobar disease with adequate future liver remnant, still technically resectable, OR
- High risk disease features (tumor \>3 cm with macrovascular invasion or tumor \>3 cm with AFP\>400).
- No extrahepatic spread, no nodal disease, no bilateral left and right branch portal vein involvement, no hepatic vein / IVC involvement. Unilateral hepatic vein involvement is not exclusionary.
- Measurable disease per RECIST 1.1 as determined by the investigator
- Age ≥ 18 years old on the day of consent
- ECOG performance status ≤1 (Appendix XX)
- Adequate organ and marrow function, as defined below. Criteria "a," "b," "c," and "f" cannot be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose.
- Hemoglobin ≥9 g/dL
- Absolute neutrophil count ≥1000/μL
- Platelet count ≥90,000/μL
- Total bilirubin (TBL) \<2.0 mg/dL
- ASTandALT≤5×ULN
- Albumin≥2.8g/dL
- International normalized ratio(INR)≤2xULN
- Calculated creatinine clearance ≥ 40 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance
- Prior systemic therapy for hepatocellular carcinoma
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s).
- Ascites that requires ongoing paracentesis, within 6 weeks prior to the first scheduled dose, to control symptoms.
- Active or prior documented GI variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 60 days prior to registration; adequate endoscopic therapy according to institutional...
- Hepatic encephalopathy within 12 months of trial registration
- Patient currently exhibits symptomatic or uncontrolled hypertension defined as diastolic blood pressure \>90 mmHg or systolic blood pressure \>140 mmHg.
- Prior external beam radiation therapy to the liver, prior yttrium-90 radioembolization
- HBV viral load \>100 IU/mL, ongoing corticosteroid therapy \>10 mg prednisone daily, and active autoimmune disease requiring systemic therapy in the past 2 years.
- Direct tumor extension into stomach, duodenum, small or large bowel
- Active or untreated central nervous system (CNS) and leptomeningeal metastases
- History of another primary malignancy except for:
- Malignancy treated with curative intentand with no known active disease ≥ 5years before the first dose of study drug(s) and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), or human immunodeficiency...
The study team makes the final eligibility decision.
Where it's taking place
- Honolulu, Hawaii, 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 Honolulu, Hawaii, 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.