vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria 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 int