RecruitingLiver Cancer
vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Kansas Medical Center
You may qualify if…
- ✓ 1. Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent .
- ✓ 2. Males and females age ≥ 18 years.
- ✓ 3. ECOG Performance Status 0 - 1
- ✓ 4. Histologically confirmed hepatocellular carcinoma (HCC) or mixed HCC and cholangiocarcinoma either locally advanced or metastatic.
- ✓ 5. Not a candidate for surgical resection, or transplant
- ✓ 6. Child Pugh A - B7 liver function scale classification 14 days prior to entry.
- ✓ 7. Unresectable, locally-advanced or metastatic hepatocellular carcinoma. Meets normal liver and adjacent organ radiation dose constraints, which usually corresponds to tumor sizes 4 - 12 cm in diameter. Tumors that are larger than 12cm are permitted provided radiation dose constraints to adjacent normal tissue are met per radiation dose constraint table
- ✓ 8. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to initiating study intervention. Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use an acceptable form of contraception for the duration of study participation, and for at least 12 months following completion of therapy. Men of child-bearing potential must agree not to donate sperm while on this study and for at least 12 months after their last study treatment.
You may not qualify if…
- ✕ 1. Hepatocelluar carcinoma (HCC) or other mixed subtype (fibrolamellar HCC, or sarcomatoid HCC) amenable to curative surgery or transplant
- ✕ 2. Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements.
- ✕ 3. Is pregnant or breastfeeding.
- ✕ 4. Prior Abdominal radiation, including prior arterial Yttrium therapy.
- ✕ 5. History of autoimmune disease.
- ✕ 6. Current use of immunosuppressive drugs, such as corticosteroids, or TNF-alpha blockers.
- ✕ 7. Concurrent active secondary malignancy, excluding indolent cancers such as treated cutaneous malignancies or treated chronic lymphocytic leukemia, or prior cancers now in remission for 3 years or longer.
- ✕ 8. Direct tumor extension into the stomach or duodenum. Small bowel or large bowel or untreated esophageal varices greater than Grade 3 are not allowed.
Where it's recruiting
Kansas
Kansas City
Source: ClinicalTrials.gov · NCT05727787 · last updated 2025-12-24