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Monoclonal Antibodies

Combination Therapy + TACE for Liver Cancer

Phase 2
Recruiting
Led By Tim F Greten, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with HCC must have BCLC C (Cohort 1) or BCLC B (Cohort 3)
Patients must have disease that is not amenable to potentially curative resection, radiofrequency ablation, or liver transplantation
Must not have
HIV-positive patients are excluded because HIV causes complicated immune deficiency and study treatment can pose more risks for these patients
Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a combination of treatment drugs to see if it can help people with advanced hepatocellular carcinoma (HCC) live longer.

Who is the study for?
Adults over 18 with advanced liver cancer (Hepatocellular Carcinoma or Biliary Tract Carcinoma) who've tried standard treatments without success, or can't tolerate them. They should be in good physical condition (ECOG 0-1), have acceptable organ function and blood counts, and no serious heart issues. Women of childbearing age and men must use contraception during the trial.
What is being tested?
The trial tests a combination therapy for liver cancer: Durvalumab, Bevacizumab, Tremelimumab injections every three weeks plus TACE - a procedure where chemotherapy beads are delivered directly to the liver tumor. The goal is to see if this combo helps patients live longer without their cancer getting worse.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion reactions from the drugs being injected into veins, increased risk of bleeding due to Bevacizumab's effect on blood vessels, fatigue from treatment intensity, and potential damage to healthy liver tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver cancer is classified as either BCLC stage C or B.
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My condition cannot be cured with surgery, ablation, or a liver transplant.
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I have a tumor that can be treated with TACE.
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I am willing to have biopsies before and after treatment.
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My liver function is relatively good despite cirrhosis.
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My condition worsened after standard chemotherapy, or I couldn't tolerate or chose not to undergo standard treatment.
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I am 18 years old or older.
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I have HBV with low viral load or HCV and agree to regular monitoring.
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My liver cancer diagnosis was confirmed through tissue examination.
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My body weight is more than 30kg.
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I can carry out all my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have HIV.
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I am on long-term steroids or other drugs that weaken my immune system.
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I do not have a bleeding disorder or significant blood clotting issues.
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I have not had major surgery in the last 6 weeks or minor procedures in the last 2 weeks.
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I do not have active brain metastases or carcinomatous meningitis.
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I have had a severe hypertension crisis or brain issues due to high blood pressure.
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I have or had serious gut conditions like Crohn's or celiac disease.
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My cancer has spread to major airways, blood vessels, or the center of my chest.
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I am not pregnant or breastfeeding.
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I have not had serious heart issues or high blood pressure crises in the last year.
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I have a serious wound, ulcer, or untreated bone fracture that is not healing.
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I take NSAID medication every day for a chronic condition.
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I do not have any severe illnesses or social situations that could affect my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the 6-month PFS in participants with BTC and HCC BCLC stage C treated with bevacizumab, durvalumab and tremelimumab
To evaluate the 6-month progression free survival (PFS) in participants with advanced HCC BCLC stage B treated with bevacizumab, durvalumab, tremelimumab and TACE
Secondary study objectives
To characterize overall survival (OS) in patients with advanced HCC and BTC treated on this study
To determine the best overall response (BOR) rate according to Response Evaluation Criteria (RECIST 1.1) in patients with advanced HCC and BTC
To determine the safety and feasibility of bevacizumab, durvalumab, tremelimumab and TACE in patients with advanced HCC
+1 more

Side effects data

From 2017 Phase 1 & 2 trial • 96 Patients • NCT01266031
100%
Headache
100%
Fatigue
83%
Lymphocyte count decreased
83%
Hemoglobin Increase
83%
Nausea
83%
Platelet count decreased
67%
Memory impairment
67%
Bicarbonate Serum-low
67%
Constipation
67%
Dizziness
67%
Gait disturbance
67%
Pyramidal Tract Dysfunction
50%
Hypoalbuminemia
50%
Hyponatremia
50%
Infection with Normal ANC (Neck NOS), (Urinary Tract NOS)
50%
METABOLIC/LABORATORY (elevated LDH)
50%
Edema limbs
50%
Leukocytosis
50%
METABOLIC/LABORATORY (Elevated BUN)
50%
Mood Alteration
50%
Speech Impairment
33%
Stomach pain
33%
Aspartate aminotransferase (AST) increased
33%
Neuropathy, Cranial (Pupil, Upper eyelid)
33%
Neuropathy, Sensory Legs/Toes tingling
33%
Taste Alteration
33%
Diplopia
33%
Muscle weakness- Whole body/generalized
33%
OCULAR/VISUAL (Right & Left visual field deficits)
33%
Hypokalemia
33%
Hypophosphatemia
33%
Alanine aminotransferase (ALT) increased
33%
Alkaline phosphatase increased
33%
Anorexia
33%
Bruising
33%
Confusion
33%
Diarrhea
33%
Gait/walking (wide based ataxic hemiparetic)
33%
Hyperglycemia
33%
Hypoglycemia
33%
METABOLIC/LABORATORY (low creatinine)
33%
METABOLIC/LABORATORY (low protein)
33%
Muscle weakness lower extremity
33%
Seizure
33%
Somnolence
17%
Dehydration
17%
DECUBITUS Ulcer Sacrum
17%
Hyperuricemia
17%
Allergic rhinitis
17%
Bloating
17%
Irregular Menses
17%
Pain (Neuropathic in perineal/buttock)
17%
Heartburn
17%
Hypocalcemia
17%
Mental Status Altered
17%
Infection with Normal ANC (Neck NOS), cellulitis
17%
METABOLIC/LABORATORY (low chloride)
17%
Mucositis oral
17%
Obstruction GI (STOMACH-small bowel nos)
17%
Epistaxis
17%
Tremor
17%
Blood bilirubin increased
17%
Blurred vision
17%
Cholesterol high
17%
Creatinine increased
17%
Cushingoid
17%
Bump at sutura site
17%
Multiple scabs
17%
Dysphagia
17%
Edema cerebral
17%
Gait/walking Impaired mobility
17%
Gastrointestinal (sensitivity to smell)
17%
Hiccups
17%
Infection with Normal ANC (Wound), Herpes Z-back-perineal-scrutum
17%
Joint Pain
17%
METABOLIC/LABORATORY (high chloride)
17%
METABOLIC/LABORATORY (low uric acid)
17%
OCULAR SURFACE DISEASE
17%
OCULAR/VISUAL (Right homonymous hemianopsia)
17%
PAIN (BACK)
17%
Pain in extremity
17%
Pruritus
17%
Sinus bradycardia
17%
Voice alteration
17%
Weight loss
17%
Sensory loss left side
17%
Dyspnea
17%
Vomiting
17%
Hypertriglycedidemia
17%
Infection with Normal ANC (Neck NOS), herpes zoster
17%
Insomnia
17%
Neuropathy, Numbness, Right sided
17%
Sore throat
17%
Urinary tract infection
17%
Hyperpigmentation (hands & knuckles)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: Vorinostat + Bevacizumab
Phase II: Bevacizumab
Phase II: Bevacizumab + Vorinostat 400 mg

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: 3/Arm 3Experimental Treatment3 Interventions
Durvalumab, low-dose bevacizumab, and tremelimumab
Group II: 2/Arm 2Experimental Treatment5 Interventions
Durvalumab, bevacizumab, tremelimumab and TACE
Group III: 1/Arm 1Experimental Treatment3 Interventions
Durvalumab, bevacizumab and tremelimumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
durvalumab
2017
Completed Phase 3
~1210
Doxorubicin-Eluting Beads
2009
Completed Phase 3
~240
TACE
2010
Completed Phase 3
~2250
bevacizumab
2002
Completed Phase 3
~3360
Tremelimumab
2017
Completed Phase 2
~3070

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,956 Previous Clinical Trials
41,112,130 Total Patients Enrolled
104 Trials studying Liver Cancer
26,538 Patients Enrolled for Liver Cancer
Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)
20 Previous Clinical Trials
1,418 Total Patients Enrolled
5 Trials studying Liver Cancer
651 Patients Enrolled for Liver Cancer

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03937830 — Phase 2
Liver Cancer Research Study Groups: 3/Arm 3, 1/Arm 1, 2/Arm 2
Liver Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03937830 — Phase 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03937830 — Phase 2
~15 spots leftby Dec 2025
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