Trial · NCT00661830

Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO)

NCT00661830, Phase 2, Completed, PD Dr Markus Möhler; results first posted 2013-11-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO). Trials, record NCT00661830. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00661830

On this page

Trial

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

Title: Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO)
NCT number: NCT00661830
Status: Completed
Phases: Phase 2
Enrollment: 103 participants, actual
Lead sponsor: PD Dr Markus Möhler
Conditions: Adenocarcinoma
Interventions: Gemcitabine, Placebo, Sorafenib
First posted: 2008-04-18
Last updated: 2013-11-21
Results first posted: 2013-11-21

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	one year	The primary endpoint is the progression-free survival (PFS) defined as the time from start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first during treatment or follow-up period. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation anti-cancer therapy. Acceptable documentation of objective disease progression status consists of objective assessments using CT scan assessment method.
Secondary	Overall Survival	one year	Overall Survival (OS) is measured from start of treatment to death due to any cause until end of follow-up period. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored at the date of the last observation.
Secondary	Best Overall Response	one year	Best Overall Response (BOR) is defined as the best tumor response (confirmed partial or complete response, stable disease) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria. Best response is determined from the sequence of responses assessed. For complete response (CR) or partial response (PR), best response must be confirmed by a second assessment within 4 -6 weeks. Two objective status determinations of CR before progression are required for a best response of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Best response of Stable Disease (SD) is defined as disease that does not meet the criteria of CR, PR or Progressive Disease (PD) and has been evaluated at least one time, at least 6 weeks after baseline assessment.
Secondary	Time to Objective Response	one year	Time to Objective Response (OR) is defined as the time from start of treatment to objective tumor response (CR or PR) is first documented according to the RECIST tumor response criteria during treatment or until 30 days after termination of active therapy. Response must subsequently be confirmed. For subjects failing to achieve an objective response and who did not progress during the trial, time to objective response will be censored at their last date of tumor evaluation.

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	Progression-free Survival (PFS)	one year	All subjects who receive at least one dose of trial treatment are included in the analysis.	days	MEDIAN
SECONDARY	Overall Survival	one year	All subjects who receive at least one dose of trial treatment are included in the analysis	days	MEDIAN
SECONDARY	Best Overall Response	one year	All subjects who receive at least one dose of trial treatment are included in the analysis.	participants	NUMBER
SECONDARY	Time to Objective Response	one year	All subjects who receive at least one dose of trial treatment and had no progression during the trial are included in the analysis	days	MEDIAN

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS)	Gemcitabine + Sorafenib		91	95% Confidence Interval 54 to 218	days
Progression-free Survival (PFS)	Gemcitabine + Placebo		148	95% Confidence Interval 105 to 233	days
Overall Survival	Gemcitabine + Sorafenib		255	95% Confidence Interval 166 to 384	days
Overall Survival	Gemcitabine + Placebo		341	95% Confidence Interval 306 to 488	days
Best Overall Response	Gemcitabine + Sorafenib	Complete response	0		participants
Best Overall Response	Gemcitabine + Placebo	Complete response	0		participants
Best Overall Response	Gemcitabine + Sorafenib	Partial response	4		participants
Best Overall Response	Gemcitabine + Placebo	Partial response	3		participants
Best Overall Response	Gemcitabine + Sorafenib	Stable disease	24		participants
Best Overall Response	Gemcitabine + Placebo	Stable disease	27		participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Gemcitabine + Sorafenib	49
Overall Study	STARTED	Gemcitabine + Placebo	48
Overall Study	COMPLETED	Gemcitabine + Sorafenib	9
Overall Study	COMPLETED	Gemcitabine + Placebo	6
Overall Study	NOT COMPLETED	Gemcitabine + Sorafenib	40
Overall Study	NOT COMPLETED	Gemcitabine + Placebo	42

Source ClinicalTrials.gov

Adverse events214

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	Fatigue	General disorders	Gemcitabine + Sorafenib	26	49	32
other	Fatigue	General disorders	Gemcitabine + Placebo	28	48	32
other	Pyrexia	General disorders	Gemcitabine + Sorafenib	11	49	17
other	Pyrexia	General disorders	Gemcitabine + Placebo	15	48	26
other	General physical health deterioration	General disorders	Gemcitabine + Sorafenib	0	49	0
other	General physical health deterioration	General disorders	Gemcitabine + Placebo	5	48	6
other	Oedema peripheral	General disorders	Gemcitabine + Sorafenib	4	49	4
other	Oedema peripheral	General disorders	Gemcitabine + Placebo	11	48	14
other	Influenza like illness	General disorders	Gemcitabine + Sorafenib	4	49	4
other	Influenza like illness	General disorders	Gemcitabine + Placebo	3	48	5

1 to 10 of 214Source ClinicalTrials.gov

See all 214 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gemcitabine + Sorafenib
Total, all-cause mortality	Gemcitabine + Placebo
Total, other adverse events	Gemcitabine + Sorafenib	47	49
Total, other adverse events	Gemcitabine + Placebo	46	48
Total, serious adverse events	Gemcitabine + Sorafenib	33	49
Total, serious adverse events	Gemcitabine + Placebo	35	48

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39905306	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
Gemcitabine + Sorafenib vs Gemcitabine + 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/NCT00661830

GET https://conductscience.org/api/trials/v1/NCT00661830/events?page=2

API reference For AI assistants