Trial · NCT03768414
Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
NCT03768414, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2024-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers. Trials, record NCT03768414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03768414
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
- NCT number
- NCT03768414
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 452 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Distal Bile Duct Cancer AJCC v8, Stage IIIA Gallbladder Cancer AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Distal Bile Duct Cancer AJCC v8, Stage IIIB Gallbladder Cancer AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Gallbladder Cancer AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Stage IVA Gallbladder Cancer AJCC v8, Stage IVB Gallbladder Cancer AJCC v8, Unresectable Extrahepatic Bile Duct Carcinoma, Unresectable Gallbladder Carcinoma, Unresectable Intrahepatic Cholangiocarcinoma
- Interventions
- Cisplatin, Gemcitabine Hydrochloride, Nab-paclitaxel
- First posted
- 2018-12-07
- Last updated
- 2026-01-12
- Results first posted
- 2024-10-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 3 years | OS will be determined using the log-rank test with stratification by disease site (gallbladder adenocarcinoma versus \[vs.\] intrahepatic cholangiocarcinoma vs. extrahepatic cholangiocarcinoma), disease stage (locally advanced vs. metastatic), and Zubrod performance status (0 vs. 1). Distributions of overall survival by treatment arm will be estimated using the method of Kaplan-Meier. |
| Secondary | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Duration of treatment and follow-up until death or 3 years post registration. | Only adverse events that are possibly, probably, or definitely related to study drugs are reported. CTCAE Version 5.0 was used for all AE reporting. |
| Secondary | Progression-free Survival (PFS) | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years | Distributions of PFS will be described using cumulative incidence estimates with differences in these estimates between treatment arms assessed by a stratified Cox regression model. |
| Secondary | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Up to 3 years | ORR is defined as confirmed and unconfirmed; complete response + partial response + stable disease. The chi-square test will be used to compare ORR, disease control rate (DCR), and rates of toxicity events across arms. ORR will be assessed in the subset of patients with measurable disease. |
| Secondary | Disease Control Rate as Measured by RECIST 1.1 Criteria | Up to 3 years | The chi-square test will be used to compare ORR, DCR, and rates of toxicity events across arms. Disease control includes confirmed and unconfirmed complete response, confirmed and unconfirmed partial response, and stable disease. In patients with non-measurable disease, disease control will be defined as those who are alive without disease progression. |
| Secondary | Changes in Carbohydrate Antigen 19-9 (CA 19-9) Levels | Baseline up to course 3 | Correlations between changes in CA19-9 levels from baseline to post-treatment and ORR will be estimated via logistic regression models, both within each treatment arm and in the overall cohort. Analyses will explore the prognostic and predictive values of CA19-9 for disease response. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to 3 years | This population includes the 441 eligible and evaluable participants. 294 in the Gem+Cisplatin+Nab-paclitaxel arm and 147 in the Gemcitabine + Cisplatin arm. | months | MEDIAN |
| SECONDARY | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Duration of treatment and follow-up until death or 3 years post registration. | Participants who were eligible and received at least one dose of protocol treatment. | Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years | This population includes the 441 eligible and evaluable participants. 294 in the Gem+Cisplatin+Nab-paclitaxel arm and 147 in the Gemcitabine + Cisplatin arm. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Up to 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Control Rate as Measured by RECIST 1.1 Criteria | Up to 3 years | percentage of participants | NUMBER | |
| SECONDARY | Changes in Carbohydrate Antigen 19-9 (CA 19-9) Levels | Baseline up to course 3 | one participant had missing baseline CA and 96 participants had missing post-treatment CA. They were not included in the analysis | U/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group218
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Gem+Cisplatin+Nab-paclitaxel | 14.0 | 95% Confidence Interval 12.4 to 16.1 | months | |
| Overall Survival (OS) | Gemcitabine + Cisplatin | 13.6 | 95% Confidence Interval 9.7 to 16.6 | months | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gem+Cisplatin+Nab-paclitaxel | Abdominal pain | 2 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gemcitabine + Cisplatin | Abdominal pain | 0 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gem+Cisplatin+Nab-paclitaxel | Acute kidney injury | 5 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gemcitabine + Cisplatin | Acute kidney injury | 3 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gem+Cisplatin+Nab-paclitaxel | Alanine aminotransferase increased | 6 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gemcitabine + Cisplatin | Alanine aminotransferase increased | 1 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gem+Cisplatin+Nab-paclitaxel | Alkaline phosphatase increased | 3 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gemcitabine + Cisplatin | Alkaline phosphatase increased | 1 | Participants |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gem+Cisplatin+Nab-paclitaxel | 294 | |
| Overall Study | STARTED | Gemcitabine + Cisplatin | 147 | |
| Overall Study | COMPLETED | Gem+Cisplatin+Nab-paclitaxel | 0 | |
| Overall Study | COMPLETED | Gemcitabine + Cisplatin | 0 | |
| Overall Study | NOT COMPLETED | Gem+Cisplatin+Nab-paclitaxel | 294 | |
| Overall Study | NOT COMPLETED | Gemcitabine + Cisplatin | 147 |
Source ClinicalTrials.gov
Adverse events262
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 | Anemia | Blood and lymphatic system disorders | Gem+Cisplatin+Nab-paclitaxel | 236 | 287 | |
| other | Anemia | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 85 | 134 | |
| other | Blood and lymphatic system disorders-Other | Blood and lymphatic system disorders | Gem+Cisplatin+Nab-paclitaxel | 15 | 287 | |
| other | Blood and lymphatic system disorders-Other | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 4 | 134 | |
| other | Sinus tachycardia | Cardiac disorders | Gem+Cisplatin+Nab-paclitaxel | 31 | 287 | |
| other | Sinus tachycardia | Cardiac disorders | Gemcitabine + Cisplatin | 17 | 134 | |
| other | Tinnitus | Ear and labyrinth disorders | Gem+Cisplatin+Nab-paclitaxel | 26 | 287 | |
| other | Tinnitus | Ear and labyrinth disorders | Gemcitabine + Cisplatin | 15 | 134 | |
| other | Blurred vision | Eye disorders | Gem+Cisplatin+Nab-paclitaxel | 21 | 287 | |
| other | Blurred vision | Eye disorders | Gemcitabine + Cisplatin | 6 | 134 |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gem+Cisplatin+Nab-paclitaxel | 237 | 294 |
| Total, all-cause mortality | Gemcitabine + Cisplatin | 115 | 147 |
| Total, other adverse events | Gem+Cisplatin+Nab-paclitaxel | 280 | 287 |
| Total, other adverse events | Gemcitabine + Cisplatin | 133 | 134 |
| Total, serious adverse events | Gem+Cisplatin+Nab-paclitaxel | 27 | 287 |
| Total, serious adverse events | Gemcitabine + Cisplatin | 11 | 134 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39671534 | 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 |
|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gem+Cisplatin+Nab-paclitaxel vs Gemcitabine + Cisplatin: deaths from any cause | Trial comparisons |
| Gem+Cisplatin+Nab-paclitaxel vs Gemcitabine + Cisplatin: 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/NCT03768414
GET https://conductscience.org/api/trials/v1/NCT03768414/results?page=2