CLINICAL TRIAL

Ipilimumab for Carcinoma, Hepatocellular

Waitlist Available · 18+ · All Sexes · Houston, TX

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.

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About the trial for Carcinoma, Hepatocellular

Eligible Conditions
Hepatocellular Carcinoma · Carcinoma, Hepatocellular · Carcinoma · Resectable Hepatocellular Carcinoma

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.

Experimental Group 1
Nivolumab
BIOLOGICAL
+
Ipilimumab
BIOLOGICAL
Experimental Group 2
Nivolumab
BIOLOGICAL
+
Ipilimumab
BIOLOGICAL
Experimental Group 3
Nivolumab
BIOLOGICAL

About The Treatment

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

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects with cancer of the liver (HCC) must have a biopsy to confirm the diagnosis and have evidence ofhelial hypervascularity with washout in order to be considered for surgery show original
A patient with HCC may have received prior surgery, radiation therapy, local-regional therapy (ablation or arterial directed therapies), and systemic therapy including sorafenib or chemotherapy show original
The person has a very good performance status and can carry out all normal activities. 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: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 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 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.

Immune response
BASELINE UP TO 2 YEARS
Will be correlated to treatment response. Immune responses, such as infiltration of CD8+/CD4+ T cells and dendritic cells, and cytokine levels in blood, will be compared between pre-treatment and post-treatment via paired t-test and Wilcoxon signed rank test. The overall treatment response rate will be summarized descriptively by dose with the n, percentage, and 95% confidence intervals. Comparison of the response rates between two treatment arms will be made via Fisher's exact test. Association between the binary overall treatment response and immune responses will be assessed by two-sample t-test and Wilcoxon rank sum test.
Progression free survival (PFS)
UP TO 5 YEARS
The Kaplan-Meier method will be used to estimate probability of PFS for each treatment arm.
Time to progression
UP TO 5 YEARS
Incidence of adverse events
UP TO 5 YEARS
Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm.
Objective response rate
UP TO 5 YEARS
Descriptive statistics including with 90% confidence interval will be computed.
Conversion rate to surgery (Arm C)
UP TO 5 YEARS
Will be estimated along with the 95% confidence interval.

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 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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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