Nitroglycerin for Liver Cancer

Not yet recruiting at 1 trial location
DF
Overseen ByDiana Flores
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether nitroglycerin, commonly used for heart conditions, can improve blood flow in liver cancer (hepatocellular carcinoma) patients during transarterial chemoembolization (TACE). Researchers will use a special imaging technique to observe changes in blood flow caused by nitroglycerin. Patients with specific, untreated liver tumors suitable for TACE may qualify for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

What prior data suggests that nitroglycerin is safe for use in liver cancer treatment?

Research has shown that nitroglycerin is generally well-tolerated in treating liver cancer. One study found that patients who received doses of 200-300 micrograms, similar to those planned for this trial, experienced increased blood flow to their tumors in 77% of cases, indicating potential treatment efficacy. The study reported no serious side effects, suggesting nitroglycerin's safety in this context. Additionally, nitroglycerin's use in other medical treatments provides some confidence in its safety. However, as this is a Phase 2 trial, further research is necessary to fully confirm its safety.12345

Why are researchers excited about this trial?

Unlike the standard treatments for liver cancer, which often focus on directly targeting tumors with chemotherapy or radiation, nitroglycerin works differently. It acts by enhancing blood flow to the liver, potentially improving the delivery and effectiveness of other treatments like transarterial chemoembolization (TACE). Researchers are excited about nitroglycerin because it leverages a new mechanism of action that could optimize existing therapies, making them more effective and possibly improving patient outcomes.

What evidence suggests that nitroglycerin might be an effective treatment for liver cancer?

Research has shown that nitroglycerin can increase blood flow by widening blood vessels, making it a common treatment for heart problems. In this trial, participants with liver cancer, specifically hepatocellular carcinoma (HCC), will receive nitroglycerin injections to potentially enhance blood flow and improve the delivery of treatments directly to the tumor. Although direct evidence for liver cancer remains limited, the mechanism of nitroglycerin makes it worth exploring. Early studies in other conditions suggest that nitroglycerin can enhance the effectiveness of some treatments, indicating it might also aid in treating HCC when combined with methods like TACE, a treatment that cuts off the tumor's blood supply.

Who Is on the Research Team?

CB

Christopher Brunson, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with liver cancer (hepatocellular carcinoma) who are able to undergo imaging and receive nitroglycerin through an artery. Specific inclusion or exclusion criteria were not listed.

Inclusion Criteria

I agree to use effective birth control during and after the study.
My tumors can be treated with standard chemoembolization.
I have or had another cancer that does not affect my current treatment's safety or results.
See 7 more

Exclusion Criteria

Hypersensitivity to nitroglycerine or its excipients
I have recently received cancer treatment within the last few weeks.
I still have side effects from previous cancer treatment that haven't improved.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo parenchymal blood volume imaging before and after intra-arterial nitroglycerin injection during standard transarterial chemoembolization (TACE) treatment

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and post-procedural assessment on days 3, 7, 30, and 90 after the procedure

90 days
4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Nitroglycerin
  • Parenchymal Blood Volume (PBV) Imaging

Trial Overview

The study tests if a special imaging method (PBV imaging) can track blood flow changes in liver tumors after giving nitroglycerin directly into the arteries. All participants receive the same treatment; there is no comparison group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Nitroglycerin InjectionExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33279371/

Quantitative Assessment of the Hemodynamic Effects ...

The mean nitroglycerin dose was 281 μg ± 69. Ten of 13 patients (77%) demonstrated a relative increase in tumor perfusion. The mean HCC to background liver area ...

Utilize Imaging to Assess Changes in Hepatocellular ...

Nitroglycerin doses ranging from 200-300 micrograms will be administered based on patient body … safety and post-procedural assessment,

3.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/liver-cancer

UCSF Liver Cancer Clinical Trials — San Francisco Bay Area

This phase I/II trial tests the safety, side effects and best dose. Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as ...

Parenchymal Blood Volume (PBV) Imaging

This phase 2 study aims to assess the proportion of participants with hepatocellular carcinoma who show at least a 30% increase in tumoral blood volume after ...

Intra-arterial Nitroglycerin Effect on Hepatocellular ...

Intra-arterial Nitroglycerin Effect on Hepatocellular Carcinoma Perfusion. Warns: This Sleeping Position Increases STROKE Risk Overnight!