Clinical trial · Interventional
TACE With or Without Radiation Therapy in Treating Patients With Stage A-C Liver Cancer
Trans-Arterial Chemo-Embolization (TACE) vs TACE Plus Stereotactic Body Radio Therapy (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator left institution
Summary
Brief summary (as posted)
This randomized phase II trial studies how well transarterial chemoembolization (TACE) works compared with TACE plus radiation therapy in treating patients with end stage liver disease, liver tumors, or potential liver transplant candidates. TACE involves reaching up to the blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor and the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that delivers radiation to the tumor cells but does not harm normal liver cells. It is not yet known whether TACE is more effective with or without SBRT in treating liver tumors.
Conditions
Conditions (5)
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 |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Stage I Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Stage II Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Stage IIIA Adult Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
| transarterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (TACE)
- description
- Patients undergo (transarterial chemoembolization) TACE according to institutional standard with doxorubicin-eluting beads.
- interventionNames
- Procedure: transarterial chemoembolization
- type
- EXPERIMENTAL
- label
- Arm II (TACE+SBRT)
- description
- Patients undergo transarterial chemoembolization (TACE) as in Arm I and 3 or 5 fractions of stereotactic radiosurgery (SBRT) given at least 48 hours apart over 14 days.
- interventionNames
- Procedure: transarterial chemoembolization
- Radiation: stereotactic radiosurgery
Primary outcomes (3)
- measure
- Percentage change in gross tumor volume (GTV)
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 A to C * Treatment with SBRT can occur within 6 weeks of registration * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Patient has * Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or * Histological confirmation of HCC as determined by the Liver Tumor Board * Hemoglobin greater than 10.0 g/dL * Total bilirubin less than 3.0 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 3 X institutional upper limit of normal * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 X institutional upper limit of normal * Total aggregate of maximal dimension of liver tumors is =\< 8 cm * Cirrhotic patients Child Pugh class A or B (score =\< 7) * Patient must be determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (magnetic resonance imaging \[MRI\]/computed tomography \[CT\] scan) three months post final treatment * Absolute neutrophil count \>= 1,500/μl * Platelet count \>= 50,000 μl (after transfusion if required) * Life expectancy \> 12 weeks * Subjects must have the ability to understand and be willing to provide written informed consent * 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 women must agree to use accepted forms of birth control; acceptable options for birth control will be documented in the consent and discussed with the subject prior to enrollment Exclusion Criteria: * Patient with previous history of abdominal radiation * Cirrhotic patients Child Pugh class B with score \>= 8 * 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 registration * Evidence of main portal vein thrombosis * History of known 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