Durvalumab for Liver carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Liver carcinoma+3 More
Durvalumab - Drug
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

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

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 preview

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.