CLINICAL TRIAL

Durvalumab for Carcinoma, Hepatocellular

Newly Diagnosed
Recruiting · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether a combination of two immunotherapy drugs may help treat liver cancer.

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About the trial for Carcinoma, Hepatocellular

Eligible Conditions
Intermediate Stage of Hepatocellular Carcinoma · Carcinoma · Carcinoma, Hepatocellular · Hepatocellular Carcinoma

Treatment Groups

This trial involves 2 different treatments. Durvalumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Tremelimumab (Cohort A dose)
DRUG
+
Durvalumab
DRUG
Experimental Group 2
Durvalumab
DRUG
+
Tremelimumab (Cohort B dose)
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Hepatocellular or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
on the Cumulative Illness Rating Scale for Elderly (>65 years) The text states that there is evidence of clinical or radiographic ascites present if the score on the Cumulative Illness Rating Scale for Elderly is < 7. show original
Please read the following information before signing the form show original
Age 18-75 years
Newly diagnosed with hepatocellular carcinoma
Have measurable disease
The text tells us that there is a disease that can be treated with DEB-TACE. show original
Eastern Cooperative Oncology Group (ECOG) defines performance status of 0 or 1 as "fully active, able to carry on all pre-disease activities without restriction. show original
Body weight >30 kg
Patients must have normal organ function as defined by study-specified laboratory tests. show original
results must be provided You must provide evidence of post-menopausal status or negative pregnancy test results in order to qualify for the program. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 4 secondary outcomes in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of 2 years.

Tumor response as determined by number of participants with partial (PR) or complete response (CR) as defined by mRECIST criteria
2 YEARS
PR is defined as >=30% reduction in size of target lesions, whereas CR is defined as disappearance of all target lesions
2 YEARS
Number of participants experiencing study drug-related toxicities
2 YEARS
Number of participants experiencing drug-related adverse events >= Grade 3 or higher as defined by CTCAE v5.0
2 YEARS
Objective response rate (ORR) using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
2 YEARS
Proportion of participants with reduction in tumor burden as defined by mRECIST criteria.
2 YEARS
Progression free survival (PFS)
2 YEARS
Number of months until disease progression or death
2 YEARS
Overall Survival (OS)
2 YEARS
Number of months until death from any-cause
2 YEARS

Patient Q & A Section

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

What are the signs of carcinoma, hepatocellular?

The signs of metastatic HCC (liver lesions, peripheral lymph node involvement, or abnormal laboratory tests) are well-defined. For a precise diagnostic algorithm, we propose that the combination of laboratory tests and imaging with ultrasound should be employed as an initial diagnostic tool with further follow-up and imaging using computed tomography or magnetic resonance imaging after negative results of these tests.

Anonymous Patient Answer

What are common treatments for carcinoma, hepatocellular?

Many cases of carcinoma, hepatocellular (hepatic carcinoma) do not receive the same aggressive treatment as the rest of the population as standard of care is not in conformity with the international guidelines of the treatment of this type of cancer. This fact generates some concerns. We hypothesize that the lack of specific treatment of these tumours in the literature might be related to differences in their epidemiology across different countries, as well as the lack of evidence of their clinical impact.

Anonymous Patient Answer

What is carcinoma, hepatocellular?

It can be found that one-fourth of patients with early HCC may have no symptoms apart from palpable liver enlargement. The most common symptoms are fever, night sweats, and weight loss. A history of HBV infection is a risk factor for early HCC.

Anonymous Patient Answer

Can carcinoma, hepatocellular be cured?

The prognosis of hepatocellular carcinoma was favorable, with a good overall survival and cure rate during the first 2 years after PFS. The 3-year local recurrence rate is acceptable. However, the development of distant metastases, especially distant hepatic recurrence and lung metastases, are potential barriers to cure of HCV-c-T4N2M0 lesions.

Anonymous Patient Answer

What causes carcinoma, hepatocellular?

Carcinoma is a complex disease, which results from a combination of factors, but the genetic and environmental influence are undoubtedly dominant. At present, the only effective method of prevention is removal of the tumors, whether liver, colorectal, ovarian, prostate or lung.

Anonymous Patient Answer

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

In this selected sample of patients with chronic liver disease and liver cirrhosis the rates of the first and second primary cancers with hepatobiliary origin in this population are very low. A substantial number of people with chronic liver disease and liver cirrhosis die of liver disease which is not known to be associated with hepatobiliary cancer. Because of their relatively low numbers, and because all patients with known risk factors are included, the data do not allow conclusions about incidence.

Anonymous Patient Answer

How serious can carcinoma, hepatocellular be?

We found that the average grade of carcinoma, hepatocellular cancer was relatively low. Most are of intermediate-late stages, however, there is still the possibility for late stage carcinoma, hepatocellular cancer. The prognosis for patients with carcinoma, hepatocellular is very poor.

Anonymous Patient Answer

What are the latest developments in durvalumab for therapeutic use?

Durvalumab is a novel monoclonal antibody that has shown potent and durable antitumour activity in subjects across a broad spectrum of cancer types and represents a significant advance for patients with refractory solid tumours. It has recently been granted orphan drug status by the FDA for the treatment of patients with HCC. It is also under consideration for use in refractory Hodgkin's lymphoma and metastatic pancreatic, ovarian and renal cell cancer. Longer follow-up is required to determine whether durvalumab achieves its anticipated clinical benefit.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinoma, hepatocellular?

From the perspective of molecular biology, targeted therapy and targeted biomarkers are two important innovations in treating hepatocellular carcinoma. Some research reports the use of gene therapy to treat hepatocarcinoma.

Anonymous Patient Answer

What is the primary cause of carcinoma, hepatocellular?

It is important to consider metastasis of multiple hepatocellular carcinomas, not only in the liver cirrhotic area. The main causes of multiple hepatocellular carcinoma are not cirrhosis and hepatitis b virus infection, but some other causes.

Anonymous Patient Answer

Is durvalumab typically used in combination with any other treatments?

Durvalumab as monotherapy and in combination with other drugs for treating patients with unresectable and/or metastatic HR+ HCC appears to generally have no clinically significant impact on OS vs chemotherapy.

Anonymous Patient Answer

Has durvalumab proven to be more effective than a placebo?

Durvalumab is more effective than a placebo, as measured by the number of disease progression-free patients and in overall survival. However, patients receiving daratumumab had a higher rate of grade 3 or 4 pulmonary toxicity. Both drug classes were associated with increased morbidity and mortality. In a recent study, findings of this study have prompted the authors to question whether anti-PDL1/PD-1 agents really improve survival or not.

Anonymous Patient Answer
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