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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My liver cancer is classified as either BCLC stage C or B.
Select...
My condition cannot be cured with surgery, ablation, or a liver transplant.
Select...
I have a tumor that can be treated with TACE.
Select...
I am willing to have biopsies before and after treatment.
Select...
My liver function is relatively good despite cirrhosis.
Select...
My condition worsened after standard chemotherapy, or I couldn't tolerate or chose not to undergo standard treatment.
Select...
I am 18 years old or older.
Select...
I have HBV with low viral load or HCV and agree to regular monitoring.
Select...
My liver cancer diagnosis was confirmed through tissue examination.
Select...
My body weight is more than 30kg.
Select...
I can carry out all my daily activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the 6-month PFS in patients with BTC and HCC BCLC stage C treated with bevacizumab, durvalumab and tremelimumab
To evaluate the 6-month progression free survival (PFS) in patients with advanced HCC BCLC stage B treated with bevacizumab, durvalumab, tremelimumab and TACE
Secondary outcome measures
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 moreSide effects data
From 2017 Phase 1 & 2 trial • 96 Patients • NCT01266031100%
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%
Neuropathy, Sensory Legs/Toes tingling
33%
Neuropathy, Cranial (Pupil, Upper eyelid)
33%
Aspartate aminotransferase (AST) increased
33%
Taste Alteration
33%
Stomach pain
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/Arm 2Experimental Treatment5 Interventions
Durvalumab, bevacizumab, tremelimumab and TACE
Group II: 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 2
~400
Doxorubicin-Eluting Beads
2009
Completed Phase 3
~240
TACE
2010
Completed Phase 3
~2190
bevacizumab
2002
Completed Phase 3
~3360
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,926,001 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)
20 Previous Clinical Trials
1,393 Total Patients Enrolled
5 Trials studying Liver Cancer
626 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is not well-controlled, even with medication.I do not have HIV.My liver cancer is classified as either BCLC stage C or B.My condition cannot be cured with surgery, ablation, or a liver transplant.I have recovered from side effects of my previous cancer treatment.I am on long-term steroids or other drugs that weaken my immune system.My kidney function is within the normal range or slightly above but still acceptable.I do not have a bleeding disorder or significant blood clotting issues.I am willing to have biopsies before and after treatment.My organ and bone marrow functions are normal.I have had a severe hypertension crisis or brain issues due to high blood pressure.My liver function is relatively good despite cirrhosis.I have taken aspirin within the last 10 days.I haven't had major blood vessel problems or surgery in the last 6 months.I had bleeding from esophageal or stomach varices in the last 6 months.I have or had serious gut conditions like Crohn's or celiac disease.My cancer has spread to major airways, blood vessels, or the center of my chest.I do not have active brain metastases or carcinomatous meningitis.I have a tumor that can be treated with TACE.I have not had major surgery in the last 6 weeks or minor procedures in the last 2 weeks.I am not pregnant or breastfeeding.My condition worsened after standard chemotherapy, or I couldn't tolerate or chose not to undergo standard treatment.My urine test shows less than 2+ protein.I have not had serious heart issues or high blood pressure crises in the last year.My cancer has been confirmed as bile duct cancer (BTC) through tests.I haven't had a clot, stroke, or heart attack in the last 6 months.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I have HBV with low viral load or HCV and agree to regular monitoring.I haven't had cancer treatment or experimental therapy in the last 4 weeks.My liver cancer diagnosis was confirmed through tissue examination.My body weight is more than 30kg.I have a serious wound, ulcer, or untreated bone fracture that is not healing.I take NSAID medication every day for a chronic condition.I have not had a gut perforation or abnormal connection in my belly in the last 6 months.You have had a strong allergic reaction to any kind of monoclonal antibody in the past.I have had a chronic autoimmune disease in the last 3 years, except for vitiligo.I have not had diverticulitis in the past 2 years.I have not coughed up more than a teaspoon of bright red blood in the last month.I can carry out all my daily activities without help.I haven't had any cancer except for some skin, bladder, or prostate cancers in the last 5 years.I do not have any severe illnesses or social situations that could affect my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Arm 1
- Group 2: 2/Arm 2
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.
What are the underlying aims of this clinical investigation?
"This clinical trial, monitored over 6 months, is designed to assess the progression-free survival of patients with advanced HCC BCLC stage B after being treated with bevacizumab, durvalumab, tremelimumab and TACE. Secondary objectives include evaluating the best overall response rate according to RECIST 1.1 criteria in such patients; characterizing their overall survival post treatment; and assessing safety/feasibility by noting adverse events type and frequency associated with these medications."
Answered by AI
What conditions typically respond well to bevacizumab treatment?
"Acute lymphoblastic leukemia is generally treated with the monoclonal antibody bevacizumab, although this drug may have other applications such as ameliorating advanced endometrial cancer and soft tissue sarcoma."
Answered by AI
Are enrollment opportunities still available for this investigation?
"According to the clinicaltrials.gov listing, this medical trial is accepting participants as of now. This program was first posted on March 10th 2021 and its details were most recently updated on October 4th 2022."
Answered by AI
Are there any other research studies that have utilized bevacizumab?
"As of now, 1024 studies pertaining to bevacizumab are ongoing with 253 in the final stage. Of those trials centered around this drug, Bethesda Maryland is hosting most; though elsewhere 49757 sites have active clinical trials for this therapeutic option."
Answered by AI
Is this experiment the inaugural attempt of its kind?
"Currently, 1024 ongoing studies for bevacizumab are located in 2721 cities across 75 nations. Alfacell's 1997 trial set the precedent; it recruited 300 participants and finalized its Phase 3 clinical assessment. Since then, 1790 more experiments have been completed with this drug."
Answered by AI
Has the Federal Drug Administration sanctioned bevacizumab?
"There is limited evidence of bevacizumab's safety, so it has been assigned a rating of 2. This Phase 2 trial has not yet obtained data which supports efficacy."
Answered by AI
How many participants are engaged in this clinical experiment?
"Affirmative, the information hosted on clinicaltrials.gov indicates that recruitment is still open for this experiment which was initially advertised on March 10th 2021 and has been recently refreshed as of October 4th 2022. 39 test subjects need to be sourced from a single site."
Answered by AI
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