Trial · NCT01465464

Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma

NCT01465464, Phase 3, Terminated, Taiho Pharmaceutical Co., Ltd.; results first posted 2019-08-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma. Trials, record NCT01465464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01465464

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
NCT number: NCT01465464
Status: Terminated
Phases: Phase 3
Enrollment: 888 participants, actual
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Conditions: Hepatocellular Carcinoma
Interventions: Orantinib (TSU-68), Placebo
First posted: 2011-11-04
Last updated: 2019-08-07
Results first posted: 2019-08-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival(OS)	The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient
Secondary	Time to Transcatheter Arterial Chemoembolization (TACE) Failure	The time from the date of enrollment to the date of event for TACE discontinuation, assessed up to three years after randomizationof the last patient	Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion. 1. The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE 2. Deterioration in arterial pathways to treat HCC that makes additional TACE impossible 3. Severe vascular invasion occurs that makes additional TACE impossible 4. Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC 5. Liver function at grade Child-Pugh class C lasting for 28 days

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival(OS)	The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient	When approximately 50% of the targeted number of time to TACE discontinuation events were confirmed, interim analysis was performed by IDMC.~Because the Committee considered that significant results would no longer be obtained, the IDMC recommended to the Sponsor that the clinical trial would be discontinued, and the Sponsor stopped this trial.	days	MEDIAN
SECONDARY	Time to Transcatheter Arterial Chemoembolization (TACE) Failure	The time from the date of enrollment to the date of event for TACE discontinuation, assessed up to three years after randomizationof the last patient	When approximately 50% of the targeted number of time to TACE discontinuation events were confirmed, interim analysis was performed by IDMC.~Because the Committee considered that significant results would no longer be obtained, the IDMC recommended to the Sponsor that the clinical trial would be discontinued, and the Sponsor stopped this trial.	days	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival(OS)	Orantinib	946.0	95% Confidence Interval 807.0 to 1050.0	days
Overall Survival(OS)	Placebo	984.0	95% Confidence Interval 864.0 to NA	days
Time to Transcatheter Arterial Chemoembolization (TACE) Failure	Orantinib	728.0	95% Confidence Interval 604.0 to 813.0	days
Time to Transcatheter Arterial Chemoembolization (TACE) Failure	Placebo	602.0	95% Confidence Interval 539.0 to 724.0	days

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Orantinib	444
Overall Study	STARTED	Placebo	444
Overall Study	COMPLETED	Orantinib	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Orantinib	444
Overall Study	NOT COMPLETED	Placebo	444

Source ClinicalTrials.gov

Adverse events554

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
other	Anaemia	Blood and lymphatic system disorders	Orantinib	54	444
other	Anaemia	Blood and lymphatic system disorders	Placebo	32	444
other	Abdominal distension	Gastrointestinal disorders	Orantinib	50	444
other	Abdominal distension	Gastrointestinal disorders	Placebo	53	444
other	Abdominal pain	Gastrointestinal disorders	Orantinib	317	444
other	Abdominal pain	Gastrointestinal disorders	Placebo	292	444
other	Abdominal pain upper	Gastrointestinal disorders	Orantinib	56	444
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	46	444
other	Ascites	Gastrointestinal disorders	Orantinib	140	444
other	Ascites	Gastrointestinal disorders	Placebo	73	444

1 to 10 of 554Source ClinicalTrials.gov

See all 554 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Orantinib	33	444
Total, all-cause mortality	Placebo	24	444
Total, other adverse events	Orantinib	443	444
Total, other adverse events	Placebo	436	444
Total, serious adverse events	Orantinib	200	444
Total, serious adverse events	Placebo	134	444

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28988687	DERIVED

Source PubMed

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
Orantinib vs Placebo: deaths from any cause	Trial comparisons
Orantinib vs Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01465464

GET https://conductscience.org/api/trials/v1/NCT01465464/events?page=2

API reference For AI assistants