Trial · NCT00919061

Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy

NCT00919061, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2016-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy. Trials, record NCT00919061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00919061

On this page

Trial

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

Title: Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy
NCT number: NCT00919061
Status: Completed
Phases: Phase 2
Enrollment: 39 participants, actual
Lead sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Interventions: Gemcitabine, Cisplatin, Sorafenib
First posted: 2009-06-12
Last updated: 2016-02-03
Results first posted: 2016-02-03

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Progression-Free Survival	6 months	Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.
Primary	Median PFS	6 mos	Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.

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	Progression-Free Survival	6 months		percentage of participants	NUMBER
PRIMARY	Median PFS	6 mos		months	MEDIAN

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Category	Value	Spread	Units
Progression-Free Survival	Gemcitabine and Cisplatin Plus Sorafenib		51	95% Confidence Interval 34 to 66	percentage of participants
Median PFS	Gemcitabine and Cisplatin Plus Sorafenib	Progression Free Survival	6.5	95% Confidence Interval 3.5 to 8.3	months
Median PFS	Gemcitabine and Cisplatin Plus Sorafenib	Overall Survival	14.4	95% Confidence Interval 11.6 to 19.2	months

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Gemcitabine and Cisplatin Plus Sorafenib	39
Overall Study	COMPLETED	Gemcitabine and Cisplatin Plus Sorafenib	37
Overall Study	NOT COMPLETED	Gemcitabine and Cisplatin Plus Sorafenib	2

Source ClinicalTrials.gov

Adverse events78

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	Alanine aminotransferase increased	Investigations	Gemcitabine and Cisplatin Plus Sorafenib	11	39	30
other	Aspartate aminotransferase increased	Investigations	Gemcitabine and Cisplatin Plus Sorafenib	8	39	12
other	Hypoalbuminemia	Metabolism and nutrition disorders	Gemcitabine and Cisplatin Plus Sorafenib	17	39	59
other	Alkaline phosphatase increased	Metabolism and nutrition disorders	Gemcitabine and Cisplatin Plus Sorafenib	16	39	69
other	Serum amylase increased	Investigations	Gemcitabine and Cisplatin Plus Sorafenib	8	39	26
other	Anorexia	Metabolism and nutrition disorders	Gemcitabine and Cisplatin Plus Sorafenib	3	39	3
other	Blood bilirubin increased	Investigations	Gemcitabine and Cisplatin Plus Sorafenib	6	39	19
other	Constipation	Gastrointestinal disorders	Gemcitabine and Cisplatin Plus Sorafenib	5	39	5
other	Creatinine increased	Investigations	Gemcitabine and Cisplatin Plus Sorafenib	2	39	13
other	Diarrhea	Gastrointestinal disorders	Gemcitabine and Cisplatin Plus Sorafenib	6	39	10

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gemcitabine and Cisplatin Plus Sorafenib
Total, other adverse events	Gemcitabine and Cisplatin Plus Sorafenib	37	39
Total, serious adverse events	Gemcitabine and Cisplatin Plus Sorafenib	24	39

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 comparisons0

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

None in this release.

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/NCT00919061

GET https://conductscience.org/api/trials/v1/NCT00919061/events?page=2

API reference For AI assistants