Clinical trial · Interventional
Combination Chemoembolization and Stereotactic Body Radiation Therapy in Unresectable Hepatocellular Carcinoma
Assessment of Response of Unresectable Hepatocellular Carcinoma to Combination Chemoembolization and Stereotactic Body Radiation Therapy
- 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)
The purpose of this study is to develop better ways to treat liver cancer, known as hepatocellular carcinoma or HCC, while it is still in the liver. Many treatments exist to treat tumors in the liver when they are small but after they grow past a certain size, local therapies such as surgery, Trans-Arterial Chemo Embolization (TACE), or Radiofrequency Ablation (RFA) are not effective. The purpose of this study to test the combination of two known treatments - TACE and Stereotactic Body Radiation Therapy (SBRT) - to be used together to treat larger or difficult to access liver tumors. Each treatment has been shown to work well but has limitations. The study will combine the treatments in an organized sequence and monitor closely how effective this combination controls tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
| TACE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with HCC
- description
- Participants with HCC with a lesion greater than 3 cm treated with TACE/SBRT combination
- interventionNames
- Radiation: SBRT
- Drug: TACE
Primary outcomes (1)
- measure
- Number of Participants With Objective Response Rate
- timeFrame
- up to 72 months
- description
- Tumor response will be assessed using mRECIST criteria as well diffusion weight imaging (DWI) via Magnetic Resonance Imaging (MRI) surveillance. * Complete response (CR): Disappearance of all target lesions * Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started * Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be diagnosed with HCC either pathologically or by the American Association for the Study of Liver Diseases (AASLD) radiographic criteria (Bruix Hepatology 2011). The criteria specifies CT or MRI intense arterial uptake followed by "washout" of contrast in the venous-delayed phases. Any atypical lesions must be confirmed by biopsy. * A single liver lesion with tumor size ≥ 3 cm as defined as maximal diameter in the axial dimension on MRI. Included in the measurement are both enhancing and non-enhancing components of the lesion. * Maximum tumor size of 7 cm as defined as maximal diameter in the axial dimension on MRI. * Age ≥ 18 years * Child-Pugh class A or B7 without ascites * ECOG score 0 * No prior treatment of current HCC. However, recurrent HCC after resection may be included. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Pregnancy which will be assessed via pregnancy test prior to TACE and repeated prior to SBRT. * Metastatic disease outside of the liver * Vascular invasion as evidenced by vessel occlusion or radiographic evidence of tumor thrombus. * Contraindications to MRI, including claustrophobia, metallic implants, and pacemakers * Tumor for which adequate radiation dosage cannot be safely delivered (see dose constraints below) * Prior therapeutic radiation therapy to the abdomen and/or lower thorax as defined as below the carina to the pelvic inlet. * Inability to provide informed consent based on persistent lack of understanding, inability to find adequate translation, impaired mental status such as mental retardation, drug induced, or traumatic brain injury. * Multiple liver tumors making the patient a BCLC Stage B * Prior treatment, except for surgical resection, to the lesion being targeted in the protocol.
References
Publications (1)
- RESULTBuckstein M, Kim E, Ozbek U, Tabrizian P, Gunasekaran G, Facciuto M, Rosenzweig K, Llovet JM, Schwartz M. Combination Transarterial Chemoembolization and Stereotactic Body Radiation Therapy for Unresectable Single Large Hepatocellular Carcinoma: Results From a Prospective Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2022 Oct 1;114(2):221-230. doi: 10.1016/j.ijrobp.2022.05.021. Epub 2022 May 26. PMID 35643250