Yttrium Y 90 Glass Microspheres for Carcinoma, Hepatocellular

Phase-Based Estimates
1
Effectiveness
1
Safety
Northwestern University, Chicago, IL
Carcinoma, Hepatocellular+2 More
Yttrium Y 90 Glass Microspheres - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Hepatocellular

Study Summary

This study is evaluating whether a combination of nivolumab and yttrium-90 may be more effective than either treatment alone.

See full description

Eligible Conditions

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Hepatocellular Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Yttrium Y 90 Glass Microspheres will improve 1 primary outcome and 3 secondary outcomes in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of Up to 30 days post-treatment.

Year 3
Overall increase in future liver remnant (FLR)
Recurrence rate
Day 30
Incidence of adverse events
Year 5
Overall survival (OS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (yttrium Y 90 glass microspheres, nivolumab)

This trial requires 2 total participants across 2 different treatment groups

This trial involves 2 different treatments. Yttrium Y 90 Glass Microspheres 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 < 1 and are in the first stage of evaluation with people.

Treatment (yttrium Y 90 glass microspheres, nivolumab)Patients receive standard of care yttrium Y 90 glass microspheres IV. Within 1-2 weeks of completing of yttrium-90 treatment, patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 4 doses in the absence of disease progression or unacceptable toxicity. If imaging shows adequate FLR and at least stable disease, patients will undergo resection within 2 weeks after the last dose of nivolumab. Patients who do not complete resection due to feasibility and have progressed or have evidence of high-risk explant may continue to receive nivolumab IV every 2 weeks for up to 1 year.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yttrium Y-90
FDA approved
Yttrium Y 90 Glass Microspheres
2016
Completed Phase 2
~110

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years post-treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years post-treatment for reporting.

Closest Location

Northwestern University - Chicago, IL

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:
Patients must have a score of 0-2 on the Eastern Cooperative Oncology Group scale. show original
OR Neutrophil count >= 70% A person has an absolute neutrophil count of 1,500/uL or a neutrophil count of at least 70%, meaning they have a high level of neutrophils. show original
to be eligible for tocilizumab therapy Patients with hepatocellular carcinoma that meets AASLD guidelines and has a Childs-Pugh score of A or B (but, <= Childs score B8) are eligible for tocilizumab therapy. show original
To be eligible for a liver resection, a patient must have a preserved hepatic function and lack of clinically significant portal hypertension. show original
NOTE: Patients with branch or lobar portal vein thrombosis (PVT) who are otherwise a candidate for resection will be included
Patients with FLR growth and/or retraction of tumor away from a major vessel must have a pre-established need for Y90 therapy in order to improve their margins. show original
Patients must have measurable disease according to the standard Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Patients with chronic hepatitis B are eligible as long as they have evidence of ongoing viral replication (detectable hepatitis B surface antigen [HBsAg], hepatitis B e-antigen [HBeAg], or hepatitis B virus [HBV] deoxyribonucleic acid [DNA]). They must have HBV DNA viral load < 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. If not on antiviral therapy at screening, then the subject must initiate treatment per regional standard of care guidelines at the time of consent. Both HBeAg positive and negative patients will be included
Hepatitis C positive patients are allowed at the doctor's discretion. show original
Leukocytes >= 2,000/mcL

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 common treatments for carcinoma, hepatocellular?

Add answer

When diagnosed at an early stage, hepatocellular carcinoma has excellent long-term outcomes with multimodal therapy. In most cases, surgery is curative because the tumor is found in a large part of the liver. In more than 90% of those cancers, the surgical procedure is hepatectomy.

Unverified Answer

What are the signs of carcinoma, hepatocellular?

Add answer

The signs of carcinoma, hepatocellular may include weakness, muscle pains and tenderness in the right lower side. Rare and uncommonly, tumors may be accompanied by high blood pressure, jaundice and enlarged liver or spleen. More than half the patients had synchronous tumors of the liver. Most of the tumors were malignant.

Unverified Answer

What causes carcinoma, hepatocellular?

Add answer

In developing countries, cirrhosis of the liver represents the most common cause of hepatocellular carcinoma. Excessive alcohol consumption and hepatitis B virus infections contribute to this development. The development of cirrhosis and consequent liver cancer may be more frequent at high altitude. Hepatitis C virus-associated hepatocellular carcinoma has become a frequent cause of morbidity in developing countries. Hepatic artery embolisation is being used more often as a curative treatment. The role of hepatitis C virus and alcohol, and HIV in the development of hepatocellular carcinoma is unknown.

Unverified Answer

Can carcinoma, hepatocellular be cured?

Add answer

Hepatocellular carcinoma can be cured when diagnosed at an early stage, when the primary pathology is HCC, and when the patient can be cured after the resective treatment. This can be realized by performing diagnostic liver biopsy at an early stage, and performing routine follow-up examinations in these patients.

Unverified Answer

What is carcinoma, hepatocellular?

Add answer

As we have stated, the primary role that the GI tract, particularly the stomach and colon, plays in carcinoma of the hepatic or biliary tract is an area that warrants continuing efforts in research to further evaluate this field of medical science. At this time, these efforts should be focused on the development of the molecular basis of carcinogenesis, particularly the study of the steps from normal tissue to preneoplastic and neoplastic change and the validation of the resultant malignancy. Such advances could be expected to lead to new and more efficacious treatments for these diseases and may be relevant to the prevention of gastric cancer.

Unverified Answer

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

Add answer

The 5-year age-adjusted incidence of HCC is very low in the United States, with annual new cases of HCC estimated at 18,000, corresponding to less than one HCC case per day for every 100,000 population in the United States. Furthermore, HCC is diagnosed in young adults, with a mean age at diagnosis of 51 years.

Unverified Answer

What does yttrium y 90 glass microspheres usually treat?

Add answer

Yttrium glass microspheres can be safely used in patients with liver cirrhosis (with a recent exception of those with a history of liver or abdominal surgery, or who are taking corticosteroids) as salvage therapy before liver transplantation for refractory, isolated liver metastases of renal cell carcinoma.

Unverified Answer

Does carcinoma, hepatocellular run in families?

Add answer

There is strong support for familial clustering of end-stage liver disease in individuals with alcoholic hepatitis, but not in individuals with primary biliary cirrhosis. Familial clustering does not seem to be due to the effects of environmental carcinogens.

Unverified Answer

What is yttrium y 90 glass microspheres?

Add answer

Yttria-90 glass microspheres were used in the treatment of pain. Yttria-90 glass microspheres (Y90) are already used in the treatment of pain in many countries. In China yttrium-90 glass microspheres were approved for use by the Food and Drug Administration in September 2004. Y90 is a radionuclide isotope for the treatment of pain in cancer patients with inoperable liver or lung cancer. It can be injected into the liver or other part of the body. The treatment is often repeated and continued with more injections.

Unverified Answer

What is the latest research for carcinoma, hepatocellular?

Add answer

Hepatocellular carcinoma may be caused by both chemical and biological factors, making it difficult to prevent. The use of statins and aspirin is an effective way to protect against hepatocellular carcinoma because they are able to inhibit a protein kinase known to play an important role in tumor development.

Unverified Answer

Is yttrium y 90 glass microspheres safe for people?

Add answer

Yttrium y 90 glass microspheres administered for metastatic hormone-refractory prostate cancer can be used safely in patients, because there are no significant safety risks associated with this therapy.

Unverified Answer

Has yttrium y 90 glass microspheres proven to be more effective than a placebo?

Add answer

Glass microspheres have been found to be more effective than a placebo in the treatment of hepatocellular carcinoma, especially in the case of patients with larger tumors in addition to those with smaller tumors.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Hepatocellular by sharing your contact details with the study coordinator.