Trial · NCT01887717
Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein
NCT01887717, Phase 3, Terminated, Boston Scientific Corporation; results first posted 2019-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein. Trials, record NCT01887717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01887717
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein
- NCT number
- NCT01887717
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 36 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Hepatocellular Carcinoma
- Interventions
- TheraSphere®, Sorafenib
- First posted
- 2013-06-27
- Last updated
- 2021-04-21
- Other registries' IDs
- eudract:2012-005375-14
- Results first posted
- 2019-10-29
- Limitations and caveats
- On 23 May 2017, the Sponsor announced early termination of the study because fewer than half of the participants remained in follow-up resulting in to few participants for the study to be continued.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) From Time of Randomization | Randomization up to participant's death (maximum time = up to Month 30) | OS was calculated as the interval between the randomization date and the date of death for any cause, with censoring at the date of last contact for participants alive. |
| Secondary | Time to Progression (TTP) | Randomization up to participant's death (maximum time = up to Month 30) | TTP was defined as the time from randomization until date of first radiological progression (including new liver lesions and extra-hepatic lesions) separately according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 criteria, modified RECIST (mRECIST) criteria, and European Association for the Study of the Liver (EASL) criteria (assessed bi-dimensionally on enhancing tissue) as assessed by Investigator determination. Progression was defined as an increase \>25% in the size of ≥1 measurable lesions (EASL) and ≥20% increase in the sum of the diameter of viable of target lesion (mRECIST). RECIST v1.1 categorized new lesions as Progressive Disease. TTP (Months)=(Date of event/censor - Date of Randomization + 1)/ 30.4375. |
| Secondary | Time to Worsening Portal Vein Thrombosis (PVT) | Baseline (Randomization) up to participant's death (maximum time = up to Month 30) | Time of randomization to time of any change in classification of PVT type by ≥1 sub-type based on Investigator assessment. At screening and every 8 weeks after, PVT categorized based on dynamic imaging studies as: Type I: segmental, in ≥1 of 8 branches of the portal vein; Type II: branched, left or right branches of the portal vein; Type III: modified on the basis of extension of the tumor thrombus; Type IIIa: eligible for study, thrombus involving the main trunk, allowing blood flow to contralateral lobe (no thrombosis); Type IIIb: NOT eligible for study, thrombus in the main portal trunk occluding blood flow to contralateral lobe; and Type IV: main PVT, NOT eligible for study, extended (mesenteric or splenic veins and/or sovra-hepatic veins). Time to Worsening of PVT (Months)=(Date of event/censor-Date of Randomization+1)/30.4375. Median time to event defined as time it is expected for half of the participants to experience the event. Data analyzed using the Kaplan-Meier method. |
| Secondary | Time to Symptomatic Progression (TTSP) | Randomization up to participant's death (maximum time = up to Month 30) | TTSP calculated as interval between randomization and symptomatic progression. Symptomatic progression defined as clinical progress to Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2 with or without tumor progression on imaging. Deterioration in PS was confirmed at the evaluation 8 weeks later. First date at which ECOG performance status was ≥2 was used as end date in TTSP analysis (assuming next subsequent visit confirmed deterioration). TTSP (Months)=(Date of ECOG \>2-Date of Randomization+1)/30.4375. ECOG PS Scale: 0=Asymptomatic and fully active; 1=Symptomatic, fully ambulatory, restricted in physically strenuous activity; 2=Symptomatic, ambulatory, capable of self-care, more than 50% of waking hours are spent out of bed; 4=Completely disabled, no self-care, bedridden. Median time to event defined as time it is expected for half of the participants to experience the event. Data analyzed using the Kaplan-Meier method. |
| Secondary | Number of Participants With Tumor Response | Baseline up to participant's death (maximum time = up to Month 30) | Tumor Response was based on the radiological tumor assessment and was categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Tumor response was assessed using RECIST version (v) 1.1, mRECIST, and EASL criteria. Criteria included: CR=disappearance of all enhanced tumor areas (EASL) and disappearance of any intratumoral arterial enhancement in all target lesions (mRECIST); PR= decrease \>50% of enhanced areas (EASL) and ≥30% decrease in the sum of diameters of viable target lesions (mRECIST); SD=neither CR, PR, PD (EASL/mRECIST); PD=an increase \>25% in the size of ≥1 measurable lesions (EASL) and ≥20% increase in the sum of the diameter of viable of target lesion (mRECIST). RECIST v 1.1 categorized new lesions as Progressive Disease only and the non-target lesions needed to have no progressive disease to be categorized as CR or PR. One month=30.4375 days. |
| Secondary | Change From Baseline in Quality of Life (QoL) as Assessed by the FACT-Hep Questionnaire | Baseline (Randomization), participant's death (maximum time = up to Month 30) | The Functional Assessment Cancer of Therapy-Hepatobiliary (FACT-Hep) Questionnaire uses participant reported outcome (PRO) scores. The FACT-Hep Trial Outcome Index (TOI) is the sum of the subscales scores in Personal Well-Being (PWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The higher the score, the better the QoL, with a range 0-128. Baseline data and change from Baseline data is presented. |
| Secondary | Time to Deterioration QoL (TTDQoL) | Baseline (Randomization) up to participant's death (maximum time = up to Month 30) | TTDQoL was calculated as the interval between the randomization date and deterioration in QoL. The FACT-Hep Questionnaire uses PRO scores. A deterioration in QoL is defined as a \>7-point decline in the total score or death, whichever occurred first. The FACT-Hep Total Score is the sum of the subscales scores in PWB, Social/Family Well-Being (SWB), Emotional Well-Being (EWB), FWB, and HCS. The higher the score, the better the QoL, with a range 0-180. TTDQoL (Months)=(Date of change from baseline in FACT-Hep ≥7 or death) - Date of Randomization + 1. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Randomization up to participant's death (maximum time = up to Month 30) | An TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of the study drug or study treatment, whether or not considered related to the treatment by the Investigator. A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or congenital anomaly. AEs included both SAEs and non-serious AEs. AEs were classified according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) and coded using the Medical Dictionary for Regulatory Activities (MedDRA). A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) From Time of Randomization | Randomization up to participant's death (maximum time = up to Month 30) | Participants who received at least 1 dose of TheraSphere or Sorafenib. | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | Randomization up to participant's death (maximum time = up to Month 30) | Participants who received at least 1 dose of TheraSphere or Sorafenib. | months | MEDIAN |
| SECONDARY | Time to Worsening Portal Vein Thrombosis (PVT) | Baseline (Randomization) up to participant's death (maximum time = up to Month 30) | Participants who received at least 1 dose of TheraSphere or Sorafenib. | months | MEDIAN |
| SECONDARY | Time to Symptomatic Progression (TTSP) | Randomization up to participant's death (maximum time = up to Month 30) | Participants who received at least 1 dose of TheraSphere or Sorafenib. | months | MEDIAN |
| SECONDARY | Number of Participants With Tumor Response | Baseline up to participant's death (maximum time = up to Month 30) | Participants who received at least 1 dose of TheraSphere or Sorafenib and with available Tumor Response data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Quality of Life (QoL) as Assessed by the FACT-Hep Questionnaire | Baseline (Randomization), participant's death (maximum time = up to Month 30) | Participants who received at least 1 dose of TheraSphere or Sorafenib and with evaluable TOI data. | score on a scale | MEAN |
| SECONDARY | Time to Deterioration QoL (TTDQoL) | Baseline (Randomization) up to participant's death (maximum time = up to Month 30) | Participants who received at least 1 dose of TheraSphere or Sorafenib. | months | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Randomization up to participant's death (maximum time = up to Month 30) | Participants who received at least 1 dose of TheraSphere or Sorafenib. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) From Time of Randomization | TheraSphere | 14.5 | Full Range 2.3 to 22.0 | months | |
| Overall Survival (OS) From Time of Randomization | Sorafenib | 18.2 | Full Range 2.9 to 18.2 | months | |
| Time to Progression (TTP) | TheraSphere | RECIST 1.1 Criteria | 6.2 | Full Range 1.6 to 18.7 | months |
| Time to Progression (TTP) | Sorafenib | RECIST 1.1 Criteria | 3.7 | Full Range 1.6 to 29.2 | months |
| Time to Progression (TTP) | TheraSphere | mRECIST Criteria | 17.0 | Full Range 1.6 to 18.7 | months |
| Time to Progression (TTP) | Sorafenib | mRECIST Criteria | 4.1 | Full Range 1.6 to 29.2 | months |
| Time to Progression (TTP) | TheraSphere | EASL Criteria | 8.1 | Full Range 1.6 to 18.7 | months |
| Time to Progression (TTP) | Sorafenib | EASL Criteria | 3.5 | Full Range 1.6 to 5.5 | months |
| Time to Worsening Portal Vein Thrombosis (PVT) | TheraSphere | 8.2 | 95% Confidence Interval 5.7 to NA | months | |
| Time to Worsening Portal Vein Thrombosis (PVT) | Sorafenib | NA | 95% Confidence Interval 1.9 to NA | months |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TheraSphere | 17 | |
| Overall Study | STARTED | Sorafenib | 19 | |
| Overall Study | Received at Least 1 Dose of Study Drug | TheraSphere | 15 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Sorafenib | 16 | |
| Overall Study | COMPLETED | TheraSphere | 11 | |
| Overall Study | COMPLETED | Sorafenib | 8 | |
| Overall Study | NOT COMPLETED | TheraSphere | 6 | |
| Overall Study | NOT COMPLETED | Sorafenib | 11 |
Source ClinicalTrials.gov
Adverse events142
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | TheraSphere | 0 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Sorafenib | 1 | 16 | |
| other | Abdominal Pain | Gastrointestinal disorders | TheraSphere | 1 | 15 | |
| other | Abdominal Pain | Gastrointestinal disorders | Sorafenib | 2 | 16 | |
| other | Aphthous Stomatitis | Gastrointestinal disorders | TheraSphere | 0 | 15 | |
| other | Aphthous Stomatitis | Gastrointestinal disorders | Sorafenib | 1 | 16 | |
| other | Ascites | Gastrointestinal disorders | TheraSphere | 1 | 15 | |
| other | Ascites | Gastrointestinal disorders | Sorafenib | 3 | 16 | |
| other | Diarrhoea | Gastrointestinal disorders | TheraSphere | 1 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Sorafenib | 7 | 16 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TheraSphere | 15 | 15 |
| Total, all-cause mortality | Sorafenib | 16 | 16 |
| Total, other adverse events | TheraSphere | 6 | 15 |
| Total, other adverse events | Sorafenib | 16 | 16 |
| Total, serious adverse events | TheraSphere | 0 | 15 |
| Total, serious adverse events | Sorafenib | 12 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TheraSphere vs Sorafenib: deaths from any cause | Trial comparisons |
| TheraSphere vs Sorafenib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01887717
GET https://conductscience.org/api/trials/v1/NCT01887717/results?page=2