Clinical trial · Interventional
Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein
A Prospective Randomized Clinical Trial on 90Yttrium Trans-arterial Radio-Embolization (TheraSphere®) vs. Standard of Care (Sorafenib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) With Portal Vein Thrombosis (PVT)
NCT01887717CI-TRIAL-00051393YES-PterminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor Accrual.
Summary
Brief summary (as posted)
This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care therapy (sorafenib) in the treatment of participants with inoperable liver cancer and blockage of the portal vein.
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 |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
| TheraSphere® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TheraSphere
- description
- Participants will receive TheraSphere at a dose consistent with the approved product label to the treated lobe of the liver. TheraSphere will be administered through the hepatic artery. The target dose will be 120 Gy + 10%. Dose reduction to a minimum dose of 80 Gy + 10% will be permitted to manage radiation exposure to the lungs. Re-treatment of the same participant/lobe with further cycles of TheraSphere will be permitted if a treatable progression is detected during follow-up evaluations. Any re-treatment will take place at least 28 days after the previous TheraSphere treatment administered to that lobe. Participants can receive a subsequent TheraSphere administration in the absence of radiological progression criteria at the Investigator's discretion. A maximum of 3 TheraSphere administrations will be permitted.
- interventionNames
- Device: TheraSphere®
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- description
- Participants will receive sorafenib, oral tablets, 400 milligrams (mg) twice daily in accordance with the package insert. Treatment is to continue until the participant is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. Medically appropriate dose adjustments and drug holidays due to adverse events (AEs) and toxicity will be allowed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants over 18 years of age, regardless of race or gender * Advanced unresectable hepatocellular carcinoma with branch portal vein thrombosis (confirmed by non-invasive criteria European Association for the Study of the Liver \[EASL\]/American Association for the Study of Liver Diseases \[AASLD\], mandatory by histology in non-cirrhotic participants); can be naive or recurrent HCC after curative treatment ( \>6 months before randomization) * Unilobar disease * Child Pugh A * Tumor volume ≤70% of liver volume (determined by visual estimation) * At least one uni-dimensional HCC target lesion assessable by computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Platelets ≥ 50\*10\^3/microliter (µL) * White blood cell (WBC) ≥1.5\*10\^3/microliter (µL) * Aspartate transaminase (AST)/ alanine aminotransferase (ALT) ≤5 times upper limit of normal * Creatinine ≤2.0 mg/deciliter (dL) * Life expectancy \>3 months * Signed informed consent Exclusion Criteria: * Confirmed extra hepatic metastases. Participants with indeterminate hepatic hilar lymph nodes up to 2.5 centimeters (cm) in greatest dimension, or with indeterminate lung nodules (single lesion between 1-1.5 cm, or multiple smaller lesions with a total diameter of ≤2 cm) may be included if metastatic disease is deemed unlikely * Known contraindication to standard-of-care sorafenib including allergic reaction, pill swallowing difficulty, uncontrolled hypertension or history of cardiac disease, significant GI bleed within 30 days, and renal failure including dialysis * Evidence of hepatic vein invasion or caval thrombosis * Evidence of chronic obstructive pulmonary disease * Indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation, transplantation) * Previous treatment with sorafenib for more than 4 weeks during the previous 2 months; prior sorafenib-related toxicity * Initiation of anti-tumor therapy including chemotherapy or investigational drug treatment within 30 days before beginning study * Prior transarterial chemoembolization (TACE) \<6 months prior to screening phase in case of participants progressing from an intermediate to an advanced stage due to occurrence of PVT * On a transplant list * History of organ allograft * Contraindications to angiography or selective visceral catheterization * History of severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically * Prior external beam radiation therapy to the liver * Evidence of continuing adverse effect of prior therapy * Active gastrointestinal (GI) bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents * Evidence of any disease or condition that would place the participant at undue risk and preclude safe use of TheraSphere treatment * Females of child-bearing potential must have a negative serum test * No participation in concurrent clinical trials
References
Publications (0)
Data not yet available
No reference posted for this study.