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Durvalumab for Liver Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California, San Francisco, San Francisco, CALiver Cancer+6 MoreDurvalumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Liver Cancer
  • Stage IIIA Hepatocellular Carcinoma
  • Stage IIIB Hepatocellular Carcinoma
  • Stage IV Liver Cancer
  • Stage IVA Hepatocellular Carcinoma
  • Stage IVB Hepatocellular Carcinoma
  • Stage III Liver Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Durvalumab
1
Durvalumab
1
Atezolizumab

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: up to 24 months

Up to 24 months
Duration of overall response (DOR)
Overall survival (OS)
Progression-free survival
up to 24 months
Number of of treatment-related adverse events
Objective response rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Durvalumab
1
Durvalumab
2
Atezolizumab

Side Effects for

DUR + R-CHOP
60%Fatigue
49%Peripheral sensory neuropathy
47%Neutropenia
40%Nausea
28%Diarrhoea
26%Decreased appetite
26%Insomnia
23%Headache
23%Alopecia
23%Dyspnoea
21%Vomiting
21%Constipation
21%Pyrexia
21%Dizziness
21%Dysgeusia
19%Hypokalaemia
19%Cough
19%Stomatitis
16%Leukopenia
16%Dry mouth
16%Anaemia
16%Rash
16%Weight decreased
16%Myalgia
14%Back pain
14%Oropharyngeal pain
14%Febrile neutropenia
12%Oedema peripheral
12%Infusion related reaction
12%Oral candidiasis
12%Abdominal pain upper
9%Thrombocytopenia
9%Urinary tract infection
9%Fall
9%Mucosal inflammation
9%Chills
9%Pruritus
7%Dry skin
7%Abdominal pain
7%Muscle spasms
7%Hypotension
7%Pain in extremity
7%Arthralgia
7%Hot flush
7%Lung infection
7%Vision blurred
7%Nasopharyngitis
7%Hypomagnesaemia
5%General physical health deterioration
5%Dysuria
5%Oral herpes
5%Atrial fibrillation
5%Pneumonia
5%Influenza
5%Infection
2%Perirectal abscess
2%Seborrhoeic dermatitis
2%Erythema
2%Pancytopenia
2%Pulmonary embolism
2%Tumour pain
2%Spinal pain
2%Venous thrombosis
2%Deep vein thrombosis
2%Gastrooesophageal reflux disease
2%Clear cell renal cell carcinoma
2%Cardiac arrest
2%Viral diarrhoea
2%Myocardial ischaemia
2%Autoimmune hepatitis
2%Device related infection
2%Lymphoma
2%Cerebrovascular accident
2%Restless legs syndrome
2%Acute kidney injury
2%Hyponatraemia
2%Histiocytosis haematophagic
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03003520) in the DUR + R-CHOP ARM group. Side effects include: Fatigue with 60%, Peripheral sensory neuropathy with 49%, Neutropenia with 47%, Nausea with 40%, Diarrhoea with 28%.

Trial Design

2 Treatment Groups

Arm I (hypofractionated RT, durvalumab)
1 of 2
Arm II (hypofractionated RT, durvalumab, tremelimumab)
1 of 2

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Durvalumab · No Placebo Group · Phase 2

Arm I (hypofractionated RT, durvalumab)Experimental Group · 2 Interventions: Durvalumab, Hypofractionated Radiation Therapy · Intervention Types: Biological, Radiation
Arm II (hypofractionated RT, durvalumab, tremelimumab)Experimental Group · 3 Interventions: Tremelimumab, Durvalumab, Hypofractionated Radiation Therapy · Intervention Types: Biological, Biological, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
Not yet FDA approved
Durvalumab
FDA approved
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

Mary Feng, MDLead Sponsor
AstraZenecaIndustry Sponsor
4,017 Previous Clinical Trials
240,375,429 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your hemoglobin level (measure of red blood cells in your blood) should be at least 9.0 grams per deciliter (g/dL).
You have enough infection-fighting white blood cells, with a count of at least 1,500/microliter (mcL).
You need to have at least 75,000 platelets per microliter of blood.
You are physically able to carry out everyday activities without being limited by your health.
If you have hepatitis B, you must be receiving treatment for it and have a low level of the virus in your blood.
You need radiation therapy for a tumor or other medical issue that could cause complications.
Your liver is functioning well, based on a scoring system called Child Pugh score.
You have liver cancer that has grown or spread while being treated with certain immunotherapy drugs like nivolumab or pembrolizumab. If you were treated with durvalumab previously, you are still eligible.
If you haven’t been diagnosed with a liver disease before, you can still participate if the diagnosis is made through radiographic imaging and it meets certain criteria set by the American Association for the Study of Liver Diseases (AASLD).
You have a tumor that can be measured using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines, and it has not been treated with radiation therapy or other local treatment before enrolling in the study.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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