Durvalumab for Carcinoma, Hepatocellular
This study is evaluating whether a combination of two immunotherapy drugs may help treat liver cancer.
See full descriptionAbout the trial for Carcinoma, Hepatocellular
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.
About The Treatment
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.