Clinical trial · Interventional
Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
NCT01668134CI-TRIAL-00026063completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic radiation
- interventionNames
- Radiation: Stereotactic radiation
Primary outcomes (1)
- measure
- Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.
- timeFrame
- Up to 90 days after end of radiation therapy
Secondary outcomes (4)
- measure
- Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.
- timeFrame
- Up to 60 days after end of radiation therapy
- measure
- Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * Karnofsky Performance Status of ≥ 60 * Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.) * 4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria. * Local surgical resection is not possible due to tumor or patient factors * Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease. * Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment * Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment * Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment. * Able to provide signed informed consent Exclusion Criteria: * Childs-Pugh score 9 or more * ALT or AST ≥ 6 x upper limit of normal * Prior history of abdominal irradiation * Women who are pregnant or nursing * Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy. * Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy. * Undergone prior radiation therapy to the abdomen.
References
Publications (0)
Data not yet available
No reference posted for this study.