Trial · NCT00881751

Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer

NCT00881751, Phase 2, Completed, Medical University of South Carolina; results first posted 2017-09-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer. Trials, record NCT00881751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00881751

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Trial

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

Title: Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer
NCT number: NCT00881751
Status: Completed
Phases: Phase 2
Enrollment: 95 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Liver Cancer
Interventions: bevacizumab, erlotinib hydrochloride, sorafenib tosylate
First posted: 2009-04-15
Last updated: 2017-09-11
Results first posted: 2017-09-11

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Overall Survival	from date of day 1 until the date of death	Overall survival is defined as the time from treatment day 1 until death from any cause. Patients still alive at the end of follow up,patients who withdrew consent from the trial and patients who were lost to follow up will have their survival time censored at the last date of contact.
Secondary	Event-free Survival	From the time of randomization until progression, withdrawal due to toxicity or any other clinical event requiring withdrawal from the study.	EFS is defined as the time from randomization to any of the following three types of events: 1 - progression; 2 - withdrawal due to excessive toxicity; 3 - any other clinical event requiring withdrawal from the study.
Secondary	Number of SAEs Experienced	From day 1 of drug administration until 30 days after the last dose of study drug.	The study will report the number of SAEs experienced in each arm. All patients who receive any study drug will be evaluable for toxicity.
Secondary	Response Rate	From day 1 drug administration until 30 days after the last dose of study drug.	Secondary outcome measures include response rate as assessed on restaging imaging studies utilizing RECIST 1.1.

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	Overall Survival	from date of day 1 until the date of death	Only subjects who received one dose of study drug were considered for this outcome. 5 subjects enrolled to Arm II did not receive any study drug and were not evaluable for this outcome.	Months	MEDIAN
SECONDARY	Event-free Survival	From the time of randomization until progression, withdrawal due to toxicity or any other clinical event requiring withdrawal from the study.		Months	MEDIAN
SECONDARY	Number of SAEs Experienced	From day 1 of drug administration until 30 days after the last dose of study drug.	Patients who received at least one dose of study drug were included in this analysis.	serious adverse events	NUMBER
SECONDARY	Response Rate	From day 1 drug administration until 30 days after the last dose of study drug.	Responders include complete and partial responders defined by RECIST 1.1 criteria.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Overall Survival	Arm I	8.55	95% Confidence Interval 7.00 to 13.9	Months
Overall Survival	Arm II	8.55	95% Confidence Interval 5.69 to 12.2	Months
Event-free Survival	Arm I	4.37	95% Confidence Interval 2.99 to 7.36	Months
Event-free Survival	Arm II	2.76	95% Confidence Interval 1.84 to 4.80	Months
Number of SAEs Experienced	Arm I	48		serious adverse events
Number of SAEs Experienced	Arm II	39		serious adverse events
Response Rate	Arm I	15		percentage of participants
Response Rate	Arm II	9		percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I	47
Overall Study	STARTED	Arm II	48
Overall Study	COMPLETED	Arm I	47
Overall Study	COMPLETED	Arm II	43
Overall Study	NOT COMPLETED	Arm I	0
Overall Study	NOT COMPLETED	Arm II	5

Source ClinicalTrials.gov

Adverse events352

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	tinnitus	Ear and labyrinth disorders	Arm I	2	47
other	tinnitus	Ear and labyrinth disorders	Arm II	3	43
other	anemia	Blood and lymphatic system disorders	Arm I	0	47
other	anemia	Blood and lymphatic system disorders	Arm II	3	43
other	hemoglobin	Blood and lymphatic system disorders	Arm I	20	47
other	hemoglobin	Blood and lymphatic system disorders	Arm II	13	43
other	neutrophils (NOS)	Investigations	Arm I	6	47
other	neutrophils (NOS)	Investigations	Arm II	3	43
other	platelets	Blood and lymphatic system disorders	Arm I	18	47
other	platelets	Blood and lymphatic system disorders	Arm II	17	43

1 to 10 of 352Source ClinicalTrials.gov

See all 352 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I
Total, all-cause mortality	Arm II
Total, other adverse events	Arm I	47	47
Total, other adverse events	Arm II	43	43
Total, serious adverse events	Arm I	25	47
Total, serious adverse events	Arm II	19	43

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 comparisons1

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

Comparison
Arm I vs Arm II: 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/NCT00881751

GET https://conductscience.org/api/trials/v1/NCT00881751/events?page=2

API reference For AI assistants