Trial · NCT02181634
Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma
NCT02181634, Phase 2, Completed, PrECOG, LLC.; results first posted 2018-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma. Trials, record NCT02181634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02181634
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma
- NCT number
- NCT02181634
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- PrECOG, LLC.
- Conditions
- Cholangiocarcinoma
- Interventions
- Nab-Paclitaxel and Gemcitabine
- First posted
- 2014-07-04
- Last updated
- 2018-10-03
- Other registries' IDs
- eudract:2015-002066-24
- Results first posted
- 2018-05-29
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months) | Assessed at 6 months | Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. Progression-free survival rate at 6 months is defined as the proportion of patients who were disease progression-free and alive at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameter/axes of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. |
| Secondary | Overall Survival (OS) | Every 3-6 months for up to 3 years | OS is defined as the time from enrollment until death or last patient contact. |
| Secondary | Progression-free Survival (PFS) | Every 3-6 months for up to 3 years | Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. |
| Secondary | Time To Progression (TTP) | Every 3-6 months for up to 3 years | TTP was defined as the time from date of first dose of study therapy to date of removal from study for progression. Patients who have not experienced progression were censored at the date of last disease evaluation. Progression is evaluated using Solid Tumor Response Criteria (RECIST) Version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters/axes of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm over the nadir. The appearance of new lesions or unequivocal progression of existing non-target lesions also constitutes disease progression. |
| Secondary | Overall Response Rate (ORR) | Every 3-6 months for up to 3 years | Overall response rate is defined as the proportion of patients with complete response or partial response per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. A confirmation assessment performed \>=4 weeks after the criteria for response is met is required. |
| Secondary | Disease Control Rate (DCR) | Every 3-6 months for up to 3 years | Disease control rate is the proportion of patients achieved complete response, partial response or stable disease per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. Stable disease is defined as neither sufficient shrinkage to qualify for complete or partial response nor sufficient increase to qualify for progression. A confirmation assessment performed \>=4 weeks after the criteria for response is met is required. |
| Secondary | Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment | Patients were dichotomized into maximum CA 19-9 decline \>=50% and maximum CA 19-9 decline \<50%. Cox proportional hazards model was used to evaluate the association between PFS and maximum change in CA 19-9. |
| Secondary | Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment | Patients were dichotomized into maximum CA 19-9 decline \>=50% and maximum CA 19-9 decline \<50%. Cox proportional hazards model was used to evaluate the association between OS and maximum change in CA 19-9. |
| Other | Change in Circulating Tumor Cells (CTCs) | Prior to Cycle 1, Day 1; Cycle 1 Day 8; Cycle 3, Day 1 and at Off Treatment | Correlate change in CTCs to median PFS, OS, TTP, ORR and DCR. |
| Other | Stromal SPARC Expression | Baseline | Correlate stromal SPARC (high versus low) expression by immunohistochemistry (IHC) with median PFS, OS, TTP, ORR and DCR. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months) | Assessed at 6 months | Eligible and treated | proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Every 3-6 months for up to 3 years | Eligible and treated | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Every 3-6 months for up to 3 years | Eligible and treated patients | months | MEDIAN |
| SECONDARY | Time To Progression (TTP) | Every 3-6 months for up to 3 years | Eligible and treated | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Every 3-6 months for up to 3 years | Eligible and treated | proportion of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Every 3-6 months for up to 3 years | Eligible and treated patients | proportion of participants | NUMBER |
| SECONDARY | Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment | Eligible and treated patients with CA 19-9 data available | months | MEDIAN |
| SECONDARY | Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment | Eligible and treated patients with CA 19-9 data available | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Change in Circulating Tumor Cells (CTCs) | Prior to Cycle 1, Day 1; Cycle 1 Day 8; Cycle 3, Day 1 and at Off Treatment | |||
| OTHER_PRE_SPECIFIED | Stromal SPARC Expression | Baseline |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group10
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) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months) | Nab-Paclitaxel and Gemcitabine | 0.605 | 95% Confidence Interval 0.482 to 0.729 | proportion of participants | |
| Overall Survival (OS) | Nab-Paclitaxel and Gemcitabine | 11.2 | 95% Confidence Interval 9.6 to 14.7 | months | |
| Progression-free Survival (PFS) | Nab-Paclitaxel and Gemcitabine | 7.7 | 95% Confidence Interval 5.9 to 13.1 | months | |
| Time To Progression (TTP) | Nab-Paclitaxel and Gemcitabine | 7.7 | 95% Confidence Interval 6.5 to 13.1 | months | |
| Overall Response Rate (ORR) | Nab-Paclitaxel and Gemcitabine | 0.301 | 95% Confidence Interval 0.199 to 0.420 | proportion of participants | |
| Disease Control Rate (DCR) | Nab-Paclitaxel and Gemcitabine | 0.658 | 95% Confidence Interval 0.537 to 0.765 | proportion of participants | |
| Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | Nab-Paclitaxel and Gemcitabine | CA 19-9 decline >=50% | 7.7 | 95% Confidence Interval 6.6 to 13.1 | months |
| Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | Nab-Paclitaxel and Gemcitabine | CA 19-9 decline <50% | 1.9 | 95% Confidence Interval 1.6 to 18.2 | months |
| Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | Nab-Paclitaxel and Gemcitabine | CA 19-9 decline >=50% | 14.6 | 95% Confidence Interval 10.2 to 25.6 | months |
| Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | Nab-Paclitaxel and Gemcitabine | CA 19-9 decline <50% | 10.2 | 95% Confidence Interval 4.1 to NA | months |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nab-Paclitaxel and Gemcitabine | 74 | |
| Overall Study | Eligible and Treated | Nab-Paclitaxel and Gemcitabine | 73 | |
| Overall Study | COMPLETED | Nab-Paclitaxel and Gemcitabine | 2 | |
| Overall Study | NOT COMPLETED | Nab-Paclitaxel and Gemcitabine | 72 |
Source ClinicalTrials.gov
Adverse events130
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 | Abdominal distension | Gastrointestinal disorders | Nab-Paclitaxel and Gemcitabine | 5 | 74 | |
| other | Abdominal pain | Gastrointestinal disorders | Nab-Paclitaxel and Gemcitabine | 12 | 74 | |
| other | Acute kidney injury | Renal and urinary disorders | Nab-Paclitaxel and Gemcitabine | 5 | 74 | |
| other | Alanine aminotransferase increased | Investigations | Nab-Paclitaxel and Gemcitabine | 18 | 74 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Nab-Paclitaxel and Gemcitabine | 39 | 74 | |
| other | Anemia | Blood and lymphatic system disorders | Nab-Paclitaxel and Gemcitabine | 31 | 74 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Nab-Paclitaxel and Gemcitabine | 13 | 74 | |
| other | Ascites | Gastrointestinal disorders | Nab-Paclitaxel and Gemcitabine | 5 | 74 | |
| other | Aspartate aminotransferase increased | Investigations | Nab-Paclitaxel and Gemcitabine | 18 | 74 | |
| other | Asthenia | General disorders | Nab-Paclitaxel and Gemcitabine | 5 | 74 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nab-Paclitaxel and Gemcitabine | ||
| Total, other adverse events | Nab-Paclitaxel and Gemcitabine | 72 | 74 |
| Total, serious adverse events | Nab-Paclitaxel and Gemcitabine | 42 | 74 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30178032 | RESULT |
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 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.
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/NCT02181634
GET https://conductscience.org/api/trials/v1/NCT02181634/events?page=2