Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Liver Cancer That Cannot be Removed by Surgery or Transplant
Downstaging of Hepatocellular Carcinoma by Stereotactic Body Radiotherapy for Non-Resectable and Non-Transplantable Tumors: Phase 2 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study being rewritten
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue in patients with liver cancer. Giving stereotactic body radiation therapy may also increase patient eligibility for liver transplant.PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with liver cancer that cannot be removed by surgery or transplant.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo 3 fractions of stereotactic body radiation therapy in 3 fractions delivered within 14 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: stereotactic body radiation therapy
Primary outcomes (1)
- measure
- Rate of downstaging of stage B and C Hepatocellular Carcinoma using Stereotactic Body Radiotherapy
- timeFrame
- At 3 months
Secondary outcomes (4)
- measure
- Rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors as assessed by NCI CTCAE version 4.0
- timeFrame
- Baseline, at 1 month, 3 months and 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * HCC is staged as Barcelona B or C (non-resectable and non-transplantable) * Treatment with SBRT can occur within 6 weeks of staging laparoscopy * Patient has a) Radiographic enhancing liver lesions on triple phase CT or MRI and b) Histological confirmation of HCC * Patients with clinical/imaging features of HCC but without biopsy confirmation can be initially enrolled on the protocol and undergo staging laparoscopy for biopsy confirmation with the option of having the fiducials placed in the same procedure; but if the histology is not confirmed and/or other exclusion criteria is met patient will be taken off protocol * Total aggregate of maximal dimension of liver tumors =\< 8 cm * Cirrhotic patients Child Pugh Class A or B * Patient should be medically eligible for liver transplantation * Absolute neutrophil count \> 1,500/ul * Platelets \> 50,000 ul (after transfusion if required) * Hemoglobin greater than 10.0 g/dL * Total bilirubin \< 2.0 mg/dL * AST(SGOT)/ALT(SGPT) \< 2 X institutional upper limit of normal * Life expectancy \> 12 weeks * ECOG performance status \< 2 or Karnofsky \>= 70% * Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment * Women must not be pregnant or nursing * Sexually active men and women must agree to use accepted forms of birth control * Provision of informed consent: Patient must be able to provide verbal and written informed consent Exclusion Criteria: * Patient with previous history of abdominal radiation * Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * Evidence of metastatic disease prior to staging laparoscopy * Evidence of main Portal Vein thrombosis * History of cardiac ischemia or stroke within last 6 months * Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppression that would constitute a contraindication to liver transplantation
References
Publications (0)
Data not yet available