Trial · NCT01402908

A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection

NCT01402908, Phase 3, Terminated, Cellxpert Biotechnology Corp.; results first posted 2020-12-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection. Trials, record NCT01402908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01402908

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Trial

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

Title: A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection
NCT number: NCT01402908
Status: Terminated
Phases: Phase 3
Enrollment: 520 participants, actual
Lead sponsor: Cellxpert Biotechnology Corp.
Conditions: Cancer, Liver Cancer, Hepatocellular Carcinoma
Interventions: PI-88, Placebo
First posted: 2011-07-26
Last updated: 2022-06-23
Results first posted: 2020-12-30

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Disease-Free Survival (DFS)	End of study	To evaluate the efficacy of daily administration of PI-88 versus placebo for the adjuvant treatment of study subjects as measured by DFS during study period. As the median DFS could not be estimated, the overall 25 th percentile DFS was reported.
Secondary	Time to Recurrence (TTR)	Time to recurrence (TTR) was defined as the time from randomization to the first time that tumor recurrence was observed or suspected during the study period (3 years).	As no subjects died without a preceding tumor recurrence , no median time to TTR could be estimated in the present study. And therefore the overall 25th percentile DFS was reported. The results of time to recurrence (TTR) were the same as that of DFS, as no subjects died without a preceding tumor recurrence.
Secondary	Overall Survival (OS)	Overall survival was defined as the time, in weeks, from randomization to death from any cause during the study period (3 years).	Overall survival was defined as the time, in weeks, from randomization to death from any cause during the study period.
Secondary	Tumor Recurrence Rate (TR Rate)	The cumulative tumor recurrence rate at weeks 5, 53, 101 and 149 was reported here.	TR rate was to calculate number of subjects with recurrence among the analyzed population.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-Free Survival (DFS)	End of study	ITT population, defined as all subjects who were randomized.	weeks	MEAN
SECONDARY	Time to Recurrence (TTR)	Time to recurrence (TTR) was defined as the time from randomization to the first time that tumor recurrence was observed or suspected during the study period (3 years).	ITT population	weeks	MEAN
SECONDARY	Overall Survival (OS)	Overall survival was defined as the time, in weeks, from randomization to death from any cause during the study period (3 years).	ITT population	weeks	MEAN
SECONDARY	Tumor Recurrence Rate (TR Rate)	The cumulative tumor recurrence rate at weeks 5, 53, 101 and 149 was reported here.	ITT population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
Disease-Free Survival (DFS)	PI-88		51.0	95% Confidence Interval 28.0 to 52.7	weeks
Disease-Free Survival (DFS)	Placebo		75.6	95% Confidence Interval 40.0 to 100.1	weeks
Time to Recurrence (TTR)	PI-88		51.0	95% Confidence Interval 28.0 to 52.7	weeks
Time to Recurrence (TTR)	Placebo		75.6	95% Confidence Interval 40.0 to 100.1	weeks
Overall Survival (OS)	PI-88		71.7	Standard Error 0.37	weeks
Overall Survival (OS)	Placebo		69.2	Standard Error 0.28	weeks
Tumor Recurrence Rate (TR Rate)	PI-88	Cumulative Tumor Recurrence Rate at weeks 5	11		Participants
Tumor Recurrence Rate (TR Rate)	Placebo	Cumulative Tumor Recurrence Rate at weeks 5	8		Participants
Tumor Recurrence Rate (TR Rate)	PI-88	Cumulative Tumor Recurrence Rate at weeks 53	74		Participants
Tumor Recurrence Rate (TR Rate)	Placebo	Cumulative Tumor Recurrence Rate at weeks 53	58		Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	PI-88	258
Overall Study	STARTED	Placebo	261
Overall Study	COMPLETED	PI-88	224
Overall Study	COMPLETED	Placebo	243
Overall Study	NOT COMPLETED	PI-88	34
Overall Study	NOT COMPLETED	Placebo	18

Source ClinicalTrials.gov

Adverse events124

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	Alopecia	Skin and subcutaneous tissue disorders	PI-88	65	258
other	Alopecia	Skin and subcutaneous tissue disorders	Placebo	7	260
other	Platelet count decreased	Investigations	PI-88	40	258
other	Platelet count decreased	Investigations	Placebo	13	260
other	Injection site haematoma	General disorders	PI-88	34	258
other	Injection site haematoma	General disorders	Placebo	7	260
other	Upper respiratory tract infection	Infections and infestations	PI-88	33	258
other	Upper respiratory tract infection	Infections and infestations	Placebo	17	260
other	Alanine aminotransferase increased	Investigations	PI-88	32	258
other	Alanine aminotransferase increased	Investigations	Placebo	23	260

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PI-88
Total, all-cause mortality	Placebo
Total, other adverse events	PI-88	233	258
Total, other adverse events	Placebo	201	260
Total, serious adverse events	PI-88	30	258
Total, serious adverse events	Placebo	15	260

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26212068	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
PI-88 vs Placebo: serious adverse events

Source 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/NCT01402908

GET https://conductscience.org/api/trials/v1/NCT01402908/events?page=2

API reference For AI assistants