Trial · NCT03278106
TAS-102 in Treating Advanced Biliary Tract Cancers
NCT03278106, Phase 2, Completed, Mayo Clinic; results first posted 2019-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TAS-102 in Treating Advanced Biliary Tract Cancers. Trials, record NCT03278106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03278106
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TAS-102 in Treating Advanced Biliary Tract Cancers
- NCT number
- NCT03278106
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Cholangiocarcinoma, Stage III Gallbladder Cancer AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7, Stage IV Gallbladder Cancer AJCC v7, Stage IVA Gallbladder Cancer AJCC v7, Stage IVB Gallbladder Cancer AJCC v7
- Interventions
- Laboratory Biomarker Analysis, Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
- First posted
- 2017-09-11
- Last updated
- 2023-06-28
- Results first posted
- 2019-10-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 16-Week Progression-free Survival (PFS) Rate | 16 weeks | 16-Week Progression-free survival (PFS) rate is defined as the percentage of patients who are progression-free (stable disease, partial response, or complete response as defined by RECIST v1.1 criteria) at 16 weeks post registration. |
| Secondary | Overall Response Rate (ORR) | Up to 3 years | ORR defined as the percentage of patients who experience either a partial response or complete response by the given time point. Complete Response (CR):All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD. |
| Secondary | Progression-free Survival (PFS) | Time from study entry to the first of either disease progression or death from any cause, assessed up to 3 years | PFS will be estimated using the Kaplan-Meier method. Progression-Free Survival (PFS) is defined as the time from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria. Patients will be censored at the last disease assessment date. The median PFS and 95% confidence interval will be reported. |
| Secondary | Overall Survival (OS) | Time from study entry to death from any cause, assessed up to 3 years | OS will be estimated using the Kaplan-Meier method. OS is defined as the time from study entry to death from any cause. Patients will be censored at the date patient was last known to be alive. The median OS and 95% confidence interval will be reported. |
| Secondary | Overall Toxicity Rates (Percentages) for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | Up to 3 years | The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. |
| Other | Change in Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA) | Baseline up to 3 years | Will correlate with efficacy endpoints. |
| Other | Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA) Analysis at Baseline | Baseline | Will determine if CTCs or cfDNA at baseline will correlate with prognosis or response to therapy. |
| Other | Mutation Status of the Tumor | Up to 3 years | Will determine if different mutations status of the tumor will affect efficacy endpoints. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 16-Week Progression-free Survival (PFS) Rate | 16 weeks | Primary analysis population | percentage of patients | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Up to 3 years | percentage of patients | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | Time from study entry to the first of either disease progression or death from any cause, assessed up to 3 years | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Time from study entry to death from any cause, assessed up to 3 years | months | MEDIAN | |
| SECONDARY | Overall Toxicity Rates (Percentages) for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | Up to 3 years | percentage of patients | NUMBER | |
| OTHER_PRE_SPECIFIED | Change in Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA) | Baseline up to 3 years | |||
| OTHER_PRE_SPECIFIED | Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA) Analysis at Baseline | Baseline | |||
| OTHER_PRE_SPECIFIED | Mutation Status of the Tumor | Up to 3 years |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 16-Week Progression-free Survival (PFS) Rate | Treatment (TAS-102) | 32.0 | 95% Confidence Interval 14.9 to 53.5 | percentage of patients | |
| Overall Response Rate (ORR) | Treatment (TAS-102) | 0 | 95% Confidence Interval 0 to 12.8 | percentage of patients | |
| Progression-free Survival (PFS) | Treatment (TAS-102) | 3.8 | 95% Confidence Interval 2.0 to 5.8 | months | |
| Overall Survival (OS) | Treatment (TAS-102) | 6.1 | 95% Confidence Interval 4.4 to 11.4 | months | |
Overall Toxicity Rates (Percentages) for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | Treatment (TAS-102) | Grade 3 | 48.1 | percentage of patients | |
Overall Toxicity Rates (Percentages) for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | Treatment (TAS-102) | Grade 4 | 11.1 | percentage of patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (TAS-102) | 28 | |
| Overall Study | COMPLETED | Treatment (TAS-102) | 27 | |
| Overall Study | NOT COMPLETED | Treatment (TAS-102) | 1 |
Source ClinicalTrials.gov
Adverse events50
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 | Treatment (TAS-102) | 25 | 27 | 83 |
| other | Watering eyes | Eye disorders | Treatment (TAS-102) | 1 | 27 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (TAS-102) | 22 | 27 | 66 |
| other | Ascites | Gastrointestinal disorders | Treatment (TAS-102) | 1 | 27 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment (TAS-102) | 5 | 27 | 9 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (TAS-102) | 12 | 27 | 36 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (TAS-102) | 2 | 27 | 3 |
| other | Nausea | Gastrointestinal disorders | Treatment (TAS-102) | 17 | 27 | 52 |
| other | Oral pain | Gastrointestinal disorders | Treatment (TAS-102) | 1 | 27 | 1 |
| other | Vomiting | Gastrointestinal disorders | Treatment (TAS-102) | 9 | 27 | 11 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (TAS-102) | 21 | 27 |
| Total, other adverse events | Treatment (TAS-102) | 27 | 27 |
| Total, serious adverse events | Treatment (TAS-102) | 10 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT03278106
GET https://conductscience.org/api/trials/v1/NCT03278106/events?page=2