Durvalumab for Portal Hypertension

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Cincinnati, Cincinnati, OH
Portal Hypertension+5 More
Durvalumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant

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Eligible Conditions

  • Portal Hypertension
  • Hepatocellular Carcinoma
  • Cirrhosis of the Liver

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 4 secondary outcomes in patients with Portal Hypertension. Measurement will happen over the course of Treatment, and up to 30 days post transplant.

Year 5
Pathologic responses via explanted liver assessment
Radiologic responses via RECIST 1.1 and/or mRECIST
Recurrence-free survival and overall survival outcomes based on survival follow up reporting
Day 30
Adverse events during treatment, and graft loss and mortality rates
Day 30
Cellular rejection rates

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Durvalumab + Tremelimumab + Liver Transplant
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Durvalumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Durvalumab + Tremelimumab + Liver TransplantPatients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Tremelimumab
Not yet FDA approved
Liver Transplant
2017
N/A
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: survival follow up will continue for 5 years after end of treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly survival follow up will continue for 5 years after end of treatment for reporting.

Closest Location

University of Cincinnati - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
ECOG score of 0 or 1
Child-Pugh Score of 5, 6, or 7
Patients must have adequate organ and marrow function as defined in protocol
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization.
Hepatocellular carcinoma, diagnosed either by biopsy or by combination of cirrhosis and imaging criteria (contrast-enhanced CT or MRI).
Tumor within UCSF criteria for transplant: either one lesion ≤6.5 cm; or up to 3 lesions, none >4.5 cm, with a total diameter ≤8 cm, with no vascular invasion and no evidence of extrahepatic disease.
Patient evaluated by institutional Liver Transplant team and listed for transplant.
No prior therapy for HCC at any time.
Age ≥18 years at the time of study entry.
Body weight >30 kg

Patient Q&A Section

What are the chances of developing carcinoma?

"While there appear to be higher risks associated with lifetime exposure to tobacco smoke, past history of alcohol abuse, and family history of pancreatic disease, risk factors do not completely explain the occurrence of pancreatic cancer. Further research into the etiology of pancreatic cancer is needed to better understand how risk factors contribute to development of this disease and the polygenic nature of its causation." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma be?

"In the United States, inpatient mortality from cancer in persons aged 65 years or older was approximately 1% for all causes during 1995 through 1999. But overall mortality from cancer among persons aged 65 years or older was 4.3% (95% confidence interval 3.8-4.7%). Cancers with the highest rates of death were lung cancer, breast cancer, colorectal cancer, and liver cancer in men; and lung cancer, cervical cancer, breast cancer, colorectal cancer, and ovarian cancer in women." - Anonymous Online Contributor

Unverified Answer

What is durvalumab?

"Durvalumab is an anti-PD-1 antibody approved by the FDA for the treatment of metastatic melanoma. There are currently no specific recommendations on the use of durvalumab for any other cancer type. In addition, there are no studies on the use of durvalumab in patients with other cancers such as lung cancer, head and neck cancer, colorectal cancer, or renal cell carcinoma. Given the limited number of eligible studies, the current evidence suggests that durvalumab should be used cautiously for patients with solid tumors and those who have received prior therapy (mainly immunotherapy and chemotherapy), due to the risk of severe immune-suppression." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma spread?

"Recent findings suggest that tumors that spread later have fewer lymph nodes involved (LN-) when compared with LN+ tumors. This suggests that the extent of tumor spread into regional lymph nodes influences survival and may affect the usefulness of the current staging system." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma a year in the United States?

"Carcinoma occurs more frequently among whites than blacks (1.4% versus 0.7%) or Hispanics (0.8% versus 0.5%), but the severity of the disease varied little among races." - Anonymous Online Contributor

Unverified Answer

Is durvalumab safe for people?

"The overall safety profile of durvalumab was acceptable In a recent study population with metastatic colorectal cancer. Durvalumab showed efficacy and quality of life benefits when added to standard care in this group of patients." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma?

"As we have shown, there has been much progress in the field of carcinoma research. Higher levels of P53 expression correlate with lower DFS, higher levels of EGFR expression correlate with worse survival, and high levels of MMP-7 expression correlate with poor overall survival. There also appears to be a correlation between the progression of stages and the corresponding changes in gene expression. These data suggest that there may be a role for targeted therapies in mcn cancers." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma?

"The cause of carcinoma is not clear but is believed to involve environmental factors such as smoking, alcohol, infections with HPV and hepatitis B virus, and metabolic changes due to obesity and type 2 diabetes. There is some evidence that genetics plays a role.\n\nThe Mayo Clinic Cancer Center conducts clinical trials at all three Mayo campuses in Rochester, Minnesota; Jacksonville, Florida; and Phoenix, Arizona. It is one of only two comprehensive cancer centers in Western New York.\n\nThe Center has been a member of the American College of Surgeons' National Surgical Quality Improvement Program since 2006 and was granted full accreditation in 2016." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of durvalumab?

"The most common adverse events occurring in ≥1% of patients treated with durvalumab were fatigue (60%), upper respiratory tract infection (11%), pneumonitis (8%), nausea (7%), dyspnoea (6%), diarrhoea (5%), headache (5%), myalgia (5%) and constipation (4%). Patients receiving durvalumab had similar rates of severe adverse events compared to those receiving placebo. In contrast, patients receiving sorafenib (marketed as Nexavar® for hepatocellular carcinoma), an anti-angiogenic agent used to treat HCC (hepatatic carcinoma), experienced more serious adverse events than patients taking placebo." - Anonymous Online Contributor

Unverified Answer

What is carcinoma?

"The word carcinoma is derived from the Greek "karkinos" meaning “a sore” or “a ulcer”, and "oma", meaning “disease, tumour”. This term was used because tumors were thought to arise due to an inflammation caused by a disease that had already begun. Because of this confusion, other terms (such as cancerous neoplasm) were sometimes used to describe tumors. These terms are still commonly used today to describe malignant tumors. \n\nCarcinoma is not a single entity; rather, there are several different types of cancer that are either true cancers or pseudo-cancers." - 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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