Durvalumab for Liver carcinoma

Phase-Based Progress Estimates

Effectiveness

Safety

Liver carcinoma+3 More

Durvalumab - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial will test a new cancer treatment involving two drugs and a medical procedure. The goal is to see if it is safe and effective for people with liver cancer.

Eligible Conditions

Liver carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Liver carcinoma

Durvalumab

durvalumab

Durvalumab

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 2 years

2 years

Number of participants experiencing study drug-related toxicities

Objective response rate (ORR) using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.

Overall Survival (OS)

Progression free survival (PFS)

Tumor response as determined by number of participants with partial (PR) or complete response (CR) as defined by mRECIST criteria

Trial Safety

Safety Progress

2 of 3

This is further along than 68% of similar trials

Other trials for Liver carcinoma

Durvalumab

durvalumab

Durvalumab

Side Effects for

DUR + R-CHOP

60%Fatigue

49%Peripheral sensory neuropathy

47%Neutropenia

40%Nausea

28%Diarrhoea

26%Decreased appetite

26%Insomnia

23%Dyspnoea

23%Alopecia

23%Headache

21%Dizziness

21%Pyrexia

21%Vomiting

21%Constipation

21%Dysgeusia

19%Hypokalaemia

19%Cough

19%Stomatitis

16%Anaemia

16%Weight decreased

16%Rash

16%Dry mouth

16%Leukopenia

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%Mucosal inflammation

9%Thrombocytopenia

9%Fall

9%Urinary tract infection

9%Chills

9%Pruritus

7%Lung infection

7%Pain in extremity

7%Arthralgia

7%Abdominal pain

7%Dry skin

7%Hot flush

7%Muscle spasms

7%Hypotension

7%Vision blurred

7%Nasopharyngitis

7%Hypomagnesaemia

5%Atrial fibrillation

5%Pneumonia

5%Dysuria

5%General physical health deterioration

5%Oral herpes

5%Influenza

5%Infection

2%Lymphoma

2%Gastrooesophageal reflux disease

2%Device related infection

2%Myocardial ischaemia

2%Erythema

2%Pulmonary embolism

2%Spinal pain

2%Perirectal abscess

2%Clear cell renal cell carcinoma

2%Venous thrombosis

2%Cardiac arrest

2%Pancytopenia

2%Tumour pain

2%Seborrhoeic dermatitis

2%Deep vein thrombosis

2%Viral diarrhoea

2%Cerebrovascular accident

2%Restless legs syndrome

2%Autoimmune hepatitis

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

Durvalumab in combination with Tremelimumab (Cohort A dose)

1 of 2

Durvalumab in combination with Tremelimumab (Cohort B dose)

1 of 2

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Durvalumab · No Placebo Group · Phase 2

Durvalumab in combination with Tremelimumab (Cohort A dose)Experimental Group · 2 Interventions: Durvalumab, Tremelimumab (Cohort A dose) · Intervention Types: Drug, Drug

Durvalumab in combination with Tremelimumab (Cohort B dose)Experimental Group · 2 Interventions: Tremelimumab (Cohort B dose), Durvalumab · Intervention Types: Drug, Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: 2 years

Who is running the clinical trial?

AstraZenecaIndustry Sponsor

3,956 Previous Clinical Trials

91,808,882 Total Patients Enrolled

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

534 Previous Clinical Trials

31,082 Total Patients Enrolled

Ana De Jesus-Acosta, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

2 Previous Clinical Trials

121 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

You have measurable disease.

You have no evidence of disease or have disease that is in a stable or controlled state.

You have a body weight of more than 30 kg.

Evidence of ascites with a score < 7.

You have adequate organ function defined by study-specified laboratory tests.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References