vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC

NCT05727787 | Recruiting DMC FDA Device

• 1 other identifier: IIT-2021-GRID-SBRT-HCC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Keywords

Liver Cancer; SBRT; Radiation Treatment

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of Single Fraction GRID SBRT

  Safely identify MTD of Single Fraction GRID SBRT and CTCAE v5.0 related toxicity: Irreversible grade 3 hepatotoxicity, grade 4 or 5 hepatotoxicity, grade 4 or 5 gastrointestinal toxicity.

  First day of post-GRID SBRT through 3 month post-radiation

Secondary Outcomes (5)

• Local control utilizing RECIST v1.1 for HCC.

  End of treatment through 3 month post-radiation

• Regional failure utilizing RECIST v1.1 for HCC.

  End of treatment through 3 month post-radiation

• Progression free survival (PFS)

  Enrollment through 3-months after end of immunotherapy treatment

• Time to Progression (TTP)

  Enrollment through 3-months after end of immunotherapy treatment

• Molecular correlatives: TCR repertoire analysis.

  Pre-vGRID vs Day 7-12 after vGRID (day 0) and 4-8 weeks after vGRID

Study Arms (1)

Single fraction SBRT 27 Gy

EXPERIMENTAL

vGRID SBRT 3+3 dose escalation, single fraction, one day cycle length

Radiation: Stereotactic Body Radiation Treatment

Interventions

Stereotactic Body Radiation Treatment RADIATION

Single fraction SBRT 27 Gy

Single fraction SBRT 27 Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent .
• Males and females age ≥ 18 years.
• ECOG Performance Status 0 - 1
• Histologically confirmed hepatocellular carcinoma (HCC) or mixed HCC and cholangiocarcinoma either locally advanced or metastatic.
• Not a candidate for surgical resection, or transplant
• Child Pugh A - B7 liver function scale classification 14 days prior to entry.
• 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
• 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.
• Adequate organ function, defined as follows: Result Date
• Hemoglobin ≥8 g/dL (The use of transfusion is acceptable)
• Absolute Neutrophil Count \> 1.0 K/UL
• Platelets \> 50 K/UL
• AST and ALT \< 6 times upper limit of normal (ULN)
• Albumin \>2.9g/dl
• Prothrombin/INR \< 1.7

You may not qualify if:

• Hepatocelluar carcinoma (HCC) or other mixed subtype (fibrolamellar HCC, or sarcomatoid HCC) amenable to curative surgery or transplant
• Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements.
• Is pregnant or breastfeeding.
• Prior Abdominal radiation, including prior arterial Yttrium therapy.
• History of autoimmune disease.
• Current use of immunosuppressive drugs, such as corticosteroids, or TNF-alpha blockers.
• 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.
• Direct tumor extension into the stomach or duodenum. Small bowel or large bowel or untreated esophageal varices greater than Grade 3 are not allowed.
• Measureable common or main branch biliary duct involvement with HCC.
• Severe active co-morbidities
• All participants: Participants should not donate blood or blood components while participating in this study and through 180 days after the last study dose.
• Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before first dose. Patients with clinically relevant ongoing complications from prior surgery are not eligible.
• History of organ transplantation.
• Uncontrolled hypertension despite optimal antihypertensive treatment in the opinion of the principal investigator.
• Uncontrollable ascites or pleural effusion.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Varian Medical Systems: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• David Akhavan, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Strider-Birkeness

CONTACT

913-945-6955; lstriderbirkeness@kumc.edu

Amanda Schroeder, MPH

CONTACT

913-588-3600; aschroeder3@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 14, 2023
• Study Start: February 23, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)