Ipilimumab for Carcinoma, Hepatocellular
This study is evaluating whether nivolumab with or without ipilimumab is safe and effective in treating patients with liver cancer that can be removed by surgery.
See full descriptionAbout the trial for Carcinoma, Hepatocellular
Treatment Groups
This trial involves 3 different treatments. Ipilimumab is the primary treatment being studied. Participants will be divided into 3 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. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Ipilimumab will improve 1 primary outcome, 4 secondary outcomes, and 1 other outcome in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of Baseline up to 2 years.
Patient Q & A Section
What causes carcinoma, hepatocellular?
Hepatocarcinoma arises from the cells of the liver due to infection by hepatitis B virus or other environmental triggers. These infected people have already compromised liver function, however the degree of impairment depends on the route of inoculation.
How many people get carcinoma, hepatocellular a year in the United States?
Approximately 500,000 people in the US were diagnosed with the disease in 2012. Many of those diagnosed were 65 years old or older, and less than 5% of the total number were female. The most common sites affected were the liver, then the brain. In the United States more than 90% of those with [liver cancer](https://www.withpower.com/clinical-trials/liver-cancer) (carcinoma, metastatic liver cancer, and other causes of liver involvement) die from liver cancer. In recent years the incidence rate of liver cancer has been increasing in the United States. Liver cancers accounted for approximately 25% of all new cases of cancer diagnosed in 2013.
What is carcinoma, hepatocellular?
The overall prevalence of adenocarcinoma, hepatocellular carcinoma, in this population was 4.1% (1208). The highest incidence rate of adenocarcinoma, hepatocellular carcinoma was in those 40-49 years of age (11.8%). The overall prevalence was higher in the male (4.1%) than in the female (2.0%). It was highest in those 40-49 years (12.2%). It was lowest in those aged 80-89 years (1.6%). The highest incidence rate of adenocarcinoma, hepatocellular carcinoma was in the non-Hispanic whites (12.8%, 20.
What are the signs of carcinoma, hepatocellular?
Hepatic encephalopathy is the most commonly observed presenting symptom in cirrhotic patients with HCC. It is often preceded by abnormal GGT elevation in the absence of encephalopathy (especially in cases of advanced liver cirrhosis).
Can carcinoma, hepatocellular be cured?
Hepatocellular cancer treatment, including chemotherapy, is the only method for curing HCC. If the tumors are small, the chances of cure are high. The best chance of cure for carcinoma, hepatocellular is if the tumors are completely removed surgically.
What are common treatments for carcinoma, hepatocellular?
Treatment modality of both resected and metastatic disease of carcinoma, hepatocellular, depends upon the clinical factors, such as: (a) the cause of hepatic disease; (b) extent of cirrhosis; (c) type, size, extent and stage of hepatic adenocarcinoma; (d) liver functional reserve; (e) presence-absence of extrahepatic disease; (f) presence/absence of extrahepatic metastasis.
How does ipilimumab work?
One of the main mechanisms of ipilimumab action is through the inhibition of tumor angiogenesis, leading to cell apoptosis. The other mechanism of action is T cell activation mediated by a specific receptor, CTLA4, which acts as an inhibitory regulator of T cell function. IPT should be used to treat patients with advanced carcinomas or who are unlikely to respond adequately to previous chemotherapy. Considering the immunosuppressive treatment that patients with ICP would receive, the immunoglobulin switch response may be a mechanism by which IPT triggers tumor regression.
What are the chances of developing carcinoma, hepatocellular?
The odds of developing carcinoma by age 75 were 2.7-fold greater in HC than in a non-HC cohort (p = 0.0001). In addition, HC patients with cirrhosis showed an incremental risk of carcinoma of 3.6-fold compared to HC patients without cirrhosis. In our cohort of HC patients, the chances of developing HCC were 2.9 times as great as in general population (p = 0.01).
Has ipilimumab proven to be more effective than a placebo?
At the end of this study, patients receiving the antibody-toxin had more pain than those taking antibody alone, but the differences were not statistically significant. When evaluating the clinical response, there was statistically significant improvement for patients on treatment compared with those on a natural history cohort. This suggests that this treatment is effective in improving symptoms of advanced and metastatic squamous cell carcinoma.
Have there been any new discoveries for treating carcinoma, hepatocellular?
Currently, research on hepatocellular carcinoma is mainly in the form of clinical trials. Most new drugs that have been successful in combating HCC are [TNF-alpha inhibitors ; the mTOR inhibitor SLC25A7; the multikinase inhibitor sorafenib (multitargeted tyrosine kinase inhibitor)]. These research results should be used to establish a new strategy for treating HCC.
How quickly does carcinoma, hepatocellular spread?
Results from a recent paper of this analysis suggest that the use of CT or MRI images can help to diagnose hepatocellular spread and that the use of liver-based staging system may be a better tool.
Is ipilimumab typically used in combination with any other treatments?
Given the efficacy of ipilimumab in combination with other treatments, which have not been well studied in the adjuvant setting, it is conceivable that ipilimumab may be useful in other treatment contexts. However, in the adjuvant setting, given similar efficacy as single agent ipilimumab, the addition of gemcitabine has not been shown to improve OS. It is important to verify in clinical trials the contribution of ipilimumab. If shown to improve OS, it would be interesting to evaluate in patients with advanced stage NSCLC who are already on systemic therapy.