Actively Recruiting
vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC
Led by University of Kansas Medical Center · Updated on 2025-12-24
18
Participants Needed
1
Research Sites
288 weeks
Total Duration
On this page
Sponsors
U
University of Kansas Medical Center
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial will provide the maximum tolerated dose for radiation therapy for liver tumors and describe the toxicity profile using the vGRID therapy technique. Based on trials using this type of radiation in other cancers demonstrating low toxicity rates even with very high radiation doses and high efficacy, it is likely that vGRID therapy in this trial will be well tolerated and allow dose escalation beyond currently common doses for liver tumors.
CONDITIONS
Official Title
vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability of participant or legally authorized representative to understand the study and willingness to sign informed consent
- Males and females aged 18 years or older
- ECOG performance status 0 or 1
- Histologically confirmed hepatocellular carcinoma (HCC) or mixed HCC and cholangiocarcinoma, locally advanced or metastatic
- Not a candidate for surgical resection or transplant
- Child Pugh A or B7 liver function within 14 days before entry
- Unresectable, locally advanced or metastatic HCC with tumor sizes usually 4 to 12 cm, or larger if radiation dose constraints are met
- Women of childbearing potential must have a negative pregnancy test within 48 hours before starting treatment
- Agreement to use contraception or abstain from sexual activity during the study and for 12 months after treatment
- Hemoglobin at least 8 g/dL (transfusions allowed)
- Absolute neutrophil count greater than 1.0 K/UL
- Platelets over 50 K/UL
- AST and ALT less than 6 times the upper limit of normal
- Albumin greater than 2.9 g/dL
- Prothrombin/INR less than 1.7
- Creatinine less than 1.5 times upper limit of normal or creatinine clearance over 60 mL/min
- Total bilirubin less than 3.0
- Esophageal varices, if present, less than Grade 2 and no bleeding in last 6 months
- Documented hepatitis B or C status; hepatitis treatment allowed
- No known or suspected untreated HIV; HIV-positive patients allowed if stable on treatment and with CD4 count above 350 cells/microliter
You will not qualify if you...
- HCC or other mixed subtype amenable to curative surgery or transplant
- Psychiatric illness or social situation limiting study compliance
- Pregnancy or breastfeeding
- Prior abdominal radiation, including arterial Yttrium therapy
- History of autoimmune disease
- Current use of immunosuppressive drugs like corticosteroids or TNF-alpha blockers
- Active secondary cancers, except certain treated indolent cancers or prior cancers in remission over 3 years
- Tumor extension into stomach, duodenum, or bowel; untreated esophageal varices greater than Grade 3
- Measurable involvement of common or main biliary duct with HCC
- Severe active co-morbidities
- Blood donation during study and 180 days after last dose prohibited
- Major surgery within 8 weeks before first treatment dose; incomplete healing
- History of organ transplantation
- Uncontrolled hypertension despite treatment
- Uncontrollable ascites or pleural effusion
- Recent abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 8 weeks
- Active autoimmune disease requiring systemic treatment in past 2 years
- Immunodeficiency or recent systemic immunosuppressive therapy within 7 days before first dose
- Significant bleeding episodes within 8 weeks
- Cholangiocarcinoma (intrahepatic or extrahepatic)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
L
Lauren Strider-Birkeness
CONTACT
A
Amanda Schroeder, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here