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Chemotherapy
Nivolumab + deb-TACE for Liver Cancer
Phase < 1
Waitlist Available
Led By James Harding, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance status 0 or 1
Child-Pugh Class A
Must not have
Vascular invasion or extrahepatic spread
History of liver allograft; prior hepatic resection is allowed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether adding the immunotherapy drug nivolumab to the standard liver cancer treatment deb-TACE improves outcomes.
Who is the study for?
Adults over 18 with confirmed liver cancer (HCC) that can't be removed by surgery or treated with a transplant. They should have measurable disease, be in good physical condition (ECOG 0 or 1), and have well-functioning bone marrow, liver, and kidneys. People with prior liver transplants, certain other cancers, severe allergies to contrast agents used in scans, HIV/AIDS, active autoimmune diseases (with some exceptions), or on high-dose steroids are excluded.
What is being tested?
The trial is testing the combination of nivolumab (an immunotherapy drug) with deb-TACE—a procedure where chemotherapy drugs are delivered directly to the liver tumor through blood vessels—to see if it's safe and works for treating liver cancer.
What are the potential side effects?
Nivolumab may cause immune-related side effects like inflammation of organs such as lungs or intestines; skin rash; hormone gland problems; infusion reactions; fatigue; and infection risk. The deb-TACE procedure might lead to abdominal pain, fever, nausea, vomiting and could potentially damage the liver.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My liver function is mildly affected.
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My kidney function is within the required range.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread beyond the liver.
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I have had a liver transplant or part of my liver removed.
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I have been treated with drugs that target the immune system.
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I am not able to have children due to menopause or surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Side effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3, deb-TACE + NivolumabExperimental Treatment2 Interventions
3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Nivolumab will be dosed every two weeks starting 4 weeks prior to deb-TACE (Week 4) and continue every 2 weeks for up to one year. If no participants experience a DLT in the initial group of 3 participants, an additional 3 participants will be added to confirm safety. If less than or equal to 1 of 6 participants experiences a DLT, this will be considered the optimal schedule.
Group II: Cohort 2, deb-TACE + NivolumabExperimental Treatment2 Interventions
3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Participants will receive nivolumab every two weeks for up to one year, starting 4 weeks prior to deb-TACE (week -4). Participants in this cohort will not receive nivolumab on the day of deb-TACE. If no participants experience a DLT in the initial group of 3 participants or if 1 of 6 participants experiences a DLT, a new group of participants will be enrolled into Cohort 3.
Group III: Cohort 1, deb-TACE + NivolumabExperimental Treatment2 Interventions
3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Two weeks after deb-TACE, participants will begin nivolumab every two weeks for up to one year. If no participants experience a dose limiting toxicity (DLT), or 1 of 6 participants experiences a DLT, a new group of participants will be enrolled into Cohort 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,231 Total Patients Enrolled
4 Trials studying Hepatocellular Carcinoma
223 Patients Enrolled for Hepatocellular Carcinoma
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,549 Total Patients Enrolled
21 Trials studying Hepatocellular Carcinoma
5,743 Patients Enrolled for Hepatocellular Carcinoma
James Harding, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
168 Total Patients Enrolled
2 Trials studying Hepatocellular Carcinoma
168 Patients Enrolled for Hepatocellular Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver, kidneys, and bone marrow are functioning well.I cannot undergo angiography/embolization due to medical reasons.You have had a serious allergic reaction to contrast dye in the past, even with medication to prevent it.My cancer has spread beyond the liver.I have had cancer before, but it was either skin cancer removed by surgery, treated cervical cancer, or another cancer that is not active and won't affect my liver cancer treatment.I am a man, sexually active with a woman capable of becoming pregnant, and will use highly effective contraception during and for 7 months after the study.My liver cancer cannot be cured with surgery, but it can be treated with a specific procedure.My liver cancer diagnosis is confirmed by my hospital's tests or I'm scheduled for a biopsy.I have had a liver transplant or part of my liver removed.I am not on high doses of steroids or other immune-weakening drugs.I am fully active or can carry out light work.My liver functions well enough for treatment, even if I'm on blood thinners.My kidney function is within the required range.My hepatitis B virus levels are low due to antiviral treatment.I have hepatitis C but am not currently being treated for it.I have an autoimmune disease but it's under control or doesn't require systemic treatment.I am using reliable birth control during and for 5 months after the study.My liver function is mildly affected.I am 18 years old or older.I've had treatments like embolization or ablation but my cancer has grown or spread.I have been treated with drugs that target the immune system.I am not able to have children due to menopause or surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2, deb-TACE + Nivolumab
- Group 2: Cohort 3, deb-TACE + Nivolumab
- Group 3: Cohort 1, deb-TACE + Nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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