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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
Adequate bone marrow, hepatic, and renal function defined as:
Disease not amenable to curative or transplant surgery (BCLC Stage B); disease must be reviewed by members of disease management team at the local enrolling institution and be amenable to deb-TACE. For the dose escalation and the expansion, regional lymphadenopathy and sub-centimeter pulmonary nodules are allowed as well as segmental portal vein involvement.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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...
My liver, kidneys, and bone marrow are functioning well.
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My liver cancer cannot be cured with surgery, but it can be treated with a specific procedure.
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My liver cancer diagnosis is confirmed by my hospital's tests or I'm scheduled for a biopsy.
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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 liver functions well enough for treatment, even if I'm on blood thinners.
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My kidney function is within the required range.
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My hepatitis B virus levels are low due to antiviral treatment.
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I have hepatitis C but am not currently being treated for it.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Neoplasm progression
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
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
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,600 Total Patients Enrolled
20 Trials studying Liver Cancer
7,826 Patients Enrolled for Liver Cancer
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,494 Total Patients Enrolled
5 Trials studying Liver Cancer
1,418 Patients Enrolled for Liver Cancer
James Harding, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
168 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical research currently seeking participants?
"At present, this trial is not searching for participants. The research was initially posted on April 28th 2017 and the last update occurred on September 27th 2022. If you are looking into other clinical trials, there are 251 studies recruiting patients with liver neoplasms and a further 717 investigations enrolling subjects in Drug Eluting Bead Transarterial Chemoembolization treatments."
Answered by AI
What precedent has been set for Drug Eluting Bead Transarterial Chemoembolization research?
"Presently, there are 717 studies underway examining the efficacy of Drug Eluting Bead Transarterial Chemoembolization. Of those, 82 have progressed to Phase 3 trials. The bulk of these investigations take place in Basel, BE; however, a total of 40291 sites across the world are running tests for this particular therapy."
Answered by AI
How many volunteers are taking part in this clinical experiment?
"At this current juncture, no individuals are being sought for enrolment. This trial was initially posted on April 28th 2017 and last modified on September 27th 2022. If you're searching for other trials, there exist 251 studies requiring participants with liver neoplasms and 717 studies in need of candidates to undergo Drug Eluting Bead Transarterial Chemoembolization treatment."
Answered by AI
In what scenarios is Drug Eluting Bead Transarterial Chemoembolization utilized?
"Drug Eluting Bead Transarterial Chemoembolization is shown to efficiently treat malignant neoplasms, such as unresectable melanoma and squamous cell carcinoma."
Answered by AI
In what geographic areas is the experiment taking place?
"Nine sites are enrolling patients in this clinical trial. These include Memorial Sloan Kettering Cancer Commack located in Commack, Washington University School of Medicine situated in Saint Louis, and Memorial Sloan Kettering at Basking Ridge based out of Basking Ridge; amongst various other locations."
Answered by AI
Is this experiment the first of its genre?
"Presently, there are 717 ongoing scientific studies that explore Drug Eluting Bead Transarterial Chemoembolization in cities and countries around the globe. This research effort was first initiated by Ono Pharmaceutical Co. Ltd back in 2012 which included 659 participants and trudged through both Phase 1 & 2 of drug approval before concluding. In total, 253 trials have been finalized since then."
Answered by AI
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