Trial · NCT02392637
Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
NCT02392637, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2022-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers. Trials, record NCT02392637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02392637
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
- NCT number
- NCT02392637
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7, Stage IVA Gallbladder Cancer AJCC v7, Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7, Stage IVB Gallbladder Cancer AJCC v7, Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7, Unresectable Extrahepatic Bile Duct Carcinoma, Unresectable Gallbladder Carcinoma
- Interventions
- Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Nab-paclitaxel
- First posted
- 2015-03-19
- Last updated
- 2022-02-02
- Results first posted
- 2022-02-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression Free Survival (PFS) | up to 3 years | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Median Overall Survival (OS) | up to 3 years | The Kaplan-Meier method was used to estimate OS, with surviving patients censored at the time of surgery or at last known follow-up. |
| Secondary | Number of Participants With Treatment Response Rate | Up to 2 years | Per Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1.14) for target lesions and assessed by MRI: Complete Response (CR),Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression Free Survival (PFS) | up to 3 years | 3 participants are not included due to 2 Discontinued during cycle 1 (adverse event) and 1 Refused treatment following cycle 1 (patient choice). The analysis for PFS were calculated for the total treated population that received both high and low dosage. | months | MEDIAN |
| SECONDARY | Median Overall Survival (OS) | up to 3 years | 3 participants are not included due to they were lost to follow up. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment Response Rate | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Median Progression Free Survival (PFS) | High Dosage | 11.4 | 95% Confidence Interval 6.0 to 15.6 | months | |
| Median Progression Free Survival (PFS) | Low Dosage | 14.9 | 95% Confidence Interval 3.8 to NA | months | |
| Median Overall Survival (OS) | High Dose | 19.5 | 95% Confidence Interval 10 to NA | months | |
| Median Overall Survival (OS) | Low Dose | 15.7 | 95% Confidence Interval 8.7 to NA | months | |
| Number of Participants With Treatment Response Rate | High Dose | Disease Control Rate(DCR) | 25 | Participants | |
| Number of Participants With Treatment Response Rate | Low Dose | Disease Control Rate(DCR) | 18 | Participants | |
| Number of Participants With Treatment Response Rate | High Dose | Complete Response(CR) | 0 | Participants | |
| Number of Participants With Treatment Response Rate | Low Dose | Complete Response(CR) | 0 | Participants | |
| Number of Participants With Treatment Response Rate | High Dose | Partial Response (PR) | 14 | Participants | |
| Number of Participants With Treatment Response Rate | Low Dose | Partial Response (PR) | 9 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High Dosage | 32 | |
| Overall Study | STARTED | Low Dosage | 28 | |
| Overall Study | COMPLETED | High Dosage | 32 | |
| Overall Study | COMPLETED | Low Dosage | 28 | |
| Overall Study | NOT COMPLETED | High Dosage | 0 | |
| Overall Study | NOT COMPLETED | Low Dosage | 0 |
Source ClinicalTrials.gov
Adverse events40
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 | Neutropenia | Blood and lymphatic system disorders | High Dose | 8 | 32 | |
| other | Neutropenia | Blood and lymphatic system disorders | Low Dose | 9 | 28 | |
| other | Anemia | Blood and lymphatic system disorders | High Dose | 6 | 32 | |
| other | Anemia | Blood and lymphatic system disorders | Low Dose | 3 | 28 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | High Dose | 4 | 32 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Low Dose | 1 | 28 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | High Dose | 1 | 32 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Low Dose | 2 | 28 | |
| other | Diarrhea | Gastrointestinal disorders | High Dose | 1 | 32 | |
| other | Diarrhea | Gastrointestinal disorders | Low Dose | 1 | 28 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose | 1 | 32 |
| Total, all-cause mortality | Low Dose | 0 | 28 |
| Total, other adverse events | High Dose | 8 | 32 |
| Total, other adverse events | Low Dose | 9 | 28 |
| Total, serious adverse events | High Dose | 5 | 32 |
| Total, serious adverse events | Low Dose | 1 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30998813 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High Dose vs Low Dose: deaths from any cause | Trial comparisons |
| High Dose vs Low Dose: serious adverse events | 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.
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/NCT02392637
GET https://conductscience.org/api/trials/v1/NCT02392637/events?page=2