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Checkpoint Inhibitor
Radiotherapy + Immunotherapy for Liver Cancer
Phase 2
Recruiting
Research Sponsored by Mary Feng, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Appropriate antiviral therapy for hepatitis B virus (HBV) with HBV DNA PCR < 2000 IU/mL
Age >=18 years, life expectancy of >= 12 weeks, body weight > 30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing whether a combination of immunotherapy drugs and radiation therapy is more effective than radiation therapy alone in treating patients with liver cancer.
Who is the study for?
This trial is for adults with advanced liver cancer that has worsened after PD-1 inhibitor therapy. They must have manageable hepatitis B, good organ function, no history of certain autoimmune diseases or immunodeficiencies, and not be on conflicting medications or treatments. Participants need to agree to use contraception and have a life expectancy of at least 12 weeks.Check my eligibility
What is being tested?
The study tests if hypofractionated radiation followed by durvalumab alone or with tremelimumab improves outcomes in liver cancer patients who've progressed on PD-1 inhibitors. It's seeing whether these drugs can boost the immune system's response against cancer when given after targeted high-dose radiation therapy.See study design
What are the potential side effects?
Possible side effects include immune-related inflammation in various organs, infusion reactions from the drug administration, fatigue, digestive issues like diarrhea, potential worsening of pre-existing autoimmune conditions, and an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on antiviral therapy for hepatitis B with low viral load.
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I am over 18, expected to live more than 12 weeks, and weigh more than 30 kg.
Select...
My blood counts and organ functions are within the required ranges.
Select...
My liver cancer has worsened despite previous immunotherapy, excluding durvalumab.
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I need radiation therapy for my condition.
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I have no known allergies or adverse reactions to immunotherapy or radiation therapy.
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I have at least one tumor that can be measured and hasn't been treated with radiation or local therapy.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Duration of overall response (DOR)
Number of of treatment-related adverse events
Overall survival (OS)
+1 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (hypofractionated RT, durvalumab, tremelimumab)Experimental Treatment3 Interventions
Patients undergo standard of care hypofractionated RT over 5 fractions QD for 5 days in the absence of disease progression or unacceptable toxicity. Within 3-10 days after completion of RT, patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with durvalumab repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who complete the first dose of tremelimumab and demonstrate clinical benefit based upon radiographic tumor regression and/or other clinical response without progression for at least 6 cycles or 6 months on treatment, whichever is shorter, and subsequently have evidence of progressive disease during the durvalumab monotherapy portion may receive a repeat dose of tremelimumab at the next scheduled cycle of treatment with durvalumab per physician discretion.
Group II: Arm I (hypofractionated RT, durvalumab)Experimental Treatment2 Interventions
Patients undergo standard of care hypofractionated RT over 5 fractions QD for 5 days in the absence of disease progression or unacceptable toxicity. Within 3-10 days after completion of RT, patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
Mary Feng, MDLead Sponsor
AstraZenecaIndustry Sponsor
4,265 Previous Clinical Trials
288,605,261 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on antiviral therapy for hepatitis B with low viral load.I haven't had major surgery or cancer treatment recently and have no ongoing side effects.I am over 18, expected to live more than 12 weeks, and weigh more than 30 kg.My liver is functioning well enough, meeting specific health criteria.I have previously been treated with CTLA-4 or PD-L1 inhibitors, or have had an organ transplant.My liver disease diagnosis was confirmed through imaging, meeting AASLD standards.My blood counts and organ functions are within the required ranges.I've had radiation that now makes further treatment unsafe.I am not using immunosuppressants, pregnant, breastfeeding, allergic to study drugs, or previously in durvalumab/tremelimumab studies.I agree to use birth control, follow the study rules, and can sign the consent form.I have not had radiation on over 30% of my bone marrow in the last 4 weeks.I do not have autoimmune diseases, uncontrolled illnesses, or a history of other cancers.My liver cancer has worsened despite previous immunotherapy, excluding durvalumab.I need radiation therapy for my condition.I have had severe side effects from previous immunotherapy that have not gone away.I have no known allergies or adverse reactions to immunotherapy or radiation therapy.I have at least one tumor that can be measured and hasn't been treated with radiation or local therapy.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (hypofractionated RT, durvalumab, tremelimumab)
- Group 2: Arm I (hypofractionated RT, durvalumab)
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.
Has Durvalumab been the focus of other scientific research projects in the past?
"There are a total of 345 clinical studies being conducted that focus on Durvalumab. Out of those, 51 have progressed to Phase 3 trials. The majority of these research projects are based in Cordoba, Texas; though, there are 13050 locations running studies for this treatment globally."
Answered by AI
Are there any available vacancies for participants in this clinical trial?
"Yes, as of today this study is still looking for volunteers. According to the clinicaltrials.gov website, the listing was first created on February 4th, 2022 and updated November 7th, 2022."
Answered by AI
How many participants are being allowed into this clinical trial?
"That is correct, the clinical trial listed on clinicaltrials.gov is still looking for patients to enroll. The study was first advertised on February 4th, and the most recent update was on November 7th. They are specifically recruiting 30 individuals from 1 site."
Answered by AI
What is the most recent data on Durvalumab's safety profile?
"The Phase 2 clinical trial status of Durvalumab means that while there is some evidence supporting its safety, its efficacy has not been studied yet."
Answered by AI
What are some of the most popular conditions that doctors treat with Durvalumab?
"Durvalumab is most commonly used to treat stage iii non-small cell lung cancer that cannot be removed surgically. Additionally, it can also be effective in treating metastatic urothelial carcinoma and advance directives."
Answered by AI
Has this type of trial been done before?
"Since 2007, Durvalumab has undergone extensive clinical trials. The first one was completed in that same year and was sponsored by AstraZeneca. After the success of this initial study with 37 participants, Durvalumab received Phase 2 drug approval. Nowadays, there are 345 active trials for Durvalumab being conducted in 1325 cities and 58 countries across the globe."
Answered by AI
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