Trial · NCT04072445
Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer
NCT04072445, Phase 2, Completed, Mayo Clinic; results first posted 2022-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer. Trials, record NCT04072445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04072445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer
- NCT number
- NCT04072445
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Advanced Bile Duct Carcinoma, Advanced Gallbladder Carcinoma, Refractory Bile Duct Carcinoma, Refractory Gallbladder Carcinoma, Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8, Stage III Intrahepatic Bile Duct Cancer AJCC v8, Stage IIIA Distal Bile Duct Cancer AJCC v8, Stage IIIA Gallbladder Cancer AJCC v8, Stage IIIA Intrahepatic Bile Duct Cancer AJCC v8, Stage IIIB Distal Bile Duct Cancer AJCC v8, Stage IIIB Gallbladder Cancer AJCC v8, Stage IIIB Intrahepatic Bile Duct Cancer AJCC v8, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Gallbladder Cancer AJCC v8, Stage IV Intrahepatic Bile Duct Cancer AJCC v8, Stage IVA Gallbladder Cancer AJCC v8, Stage IVB Gallbladder Cancer AJCC v8
- Interventions
- Irinotecan, Irinotecan Hydrochloride, Trifluridine and Tipiracil Hydrochloride
- First posted
- 2019-08-28
- Last updated
- 2023-08-09
- Results first posted
- 2022-09-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to 16 weeks | Will be defined as the proportion of evaluable patients who are progression-free (stable disease, partial response, complete response) at 16 weeks and assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson. |
| Secondary | Overall Response Rate (ORR) | Up to 20 months | Will be defined as the proportion of patients who experience either a partial response or complete response as their best response. ORR will be reported descriptively and a 95% confidence interval will be reported. |
| Secondary | Disease Control Rate (DCR) | Up to 20 months | Will be defined as the proportion of patients who experience a partial response, complete response, or have stable disease as their best response. DCR will be reported descriptively and a 95% confidence interval will be reported. |
| Secondary | PFS | From study entry to the first of either disease progression or death from any cause, assessed up to 20 months | Will be determined based on RECIST v 1.1. PFS will be estimated using the Kaplan-Meier method. The median PFS and 95% confidence interval will be reported. Patients will be censored at the last disease assessment date. |
| Secondary | Overall Survival (OS) | From study entry to death from any cause, assessed up to 20 months | Will be estimated using the Kaplan-Meier method. The median OS and 95% confidence interval will be reported. Patients will be censored at the date patient was last known to be alive. |
| Secondary | Number of Participants With Adverse Events | Up to 28 days | The maximum grade for each type of adverse event by patient will be summarized by frequencies and percentages using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. |
| Other | Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (cfDNA) at Baseline | Baseline | Will determine if CTCs or cfDNA at baseline will correlate with prognosis or response to therapy. |
| Other | Change in CTCs or cfDNA | Baseline up to 20 months | Will determine if change in CTCs or cfDNA will correlate with efficacy endpoints. |
| Other | Correlation of Response | Up to 20 months | Will determine if drug response from a parallel ex vivo trial using patient-derived tumor organoid correlates with clinical response to trifluridine and tipiracil hydrochloride (trifluridine/tipiracil) plus irinotecan hydrochloride (irinotecan). |
| Other | Prediction of Clinical Benefit by Thymidine Kinase 1 (TK1) | Baseline | Will evaluate the role of TK1 in predicting the clinical benefit of trifluridine/tipiracil plus irinotecan and discover potential mechanisms of resistance using patient-derived tumor organoid and pre-treatment biopsy specimen. |
Source ClinicalTrials.gov
Outcomes10
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) | Up to 16 weeks | percentage of participants | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) | Up to 20 months | 7 patients went off treatment early on and weren't evaluated for response post-baseline | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Up to 20 months | 7 patients went off treatment early on and weren't evaluated for response post-baseline | percentage of participants | NUMBER |
| SECONDARY | PFS | From study entry to the first of either disease progression or death from any cause, assessed up to 20 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | From study entry to death from any cause, assessed up to 20 months | months | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (cfDNA) at Baseline | Baseline | |||
| OTHER_PRE_SPECIFIED | Change in CTCs or cfDNA | Baseline up to 20 months | |||
| OTHER_PRE_SPECIFIED | Correlation of Response | Up to 20 months | |||
| OTHER_PRE_SPECIFIED | Prediction of Clinical Benefit by Thymidine Kinase 1 (TK1) | Baseline |
Source ClinicalTrials.gov
Results by group8
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) | Treatment (Trifluridine and Tipiracil, Irinotecan) | 37.0 | 95% Confidence Interval 19.4 to 57.6 | percentage of participants | |
| Overall Response Rate (ORR) | Treatment (Trifluridine and Tipiracil, Irinotecan) | 20.0 | 95% Confidence Interval 5.7 to 43.7 | percentage of participants | |
| Disease Control Rate (DCR) | Treatment (Trifluridine and Tipiracil, Irinotecan) | 50 | 95% Confidence Interval 27.2 to 72.8 | percentage of participants | |
| PFS | Treatment (Trifluridine and Tipiracil, Irinotecan) | 3.9 | 95% Confidence Interval 2.5 to 7.4 | months | |
| Overall Survival (OS) | Treatment (Trifluridine and Tipiracil, Irinotecan) | 9.1 | 95% Confidence Interval 8.0 to 14.3 | months | |
| Number of Participants With Adverse Events | Treatment (Trifluridine and Tipiracil, Irinotecan) | Grade 3+ AE | 20 | Participants | |
| Number of Participants With Adverse Events | Treatment (Trifluridine and Tipiracil, Irinotecan) | Grade 4 AE | 4 | Participants | |
| Number of Participants With Adverse Events | Treatment (Trifluridine and Tipiracil, Irinotecan) | Grade 5 AE | 0 | Participants |
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 (Trifluridine and Tipiracil, Irinotecan) | 28 | |
| Overall Study | COMPLETED | Treatment (Trifluridine and Tipiracil, Irinotecan) | 27 | |
| Overall Study | NOT COMPLETED | Treatment (Trifluridine and Tipiracil, Irinotecan) | 1 |
Source ClinicalTrials.gov
Adverse events36
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 (Trifluridine and Tipiracil, Irinotecan) | 26 | 27 | 208 |
| other | Ascites | Gastrointestinal disorders | Treatment (Trifluridine and Tipiracil, Irinotecan) | 2 | 27 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Trifluridine and Tipiracil, Irinotecan) | 6 | 27 | 9 |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | Treatment (Trifluridine and Tipiracil, Irinotecan) | 1 | 27 | 2 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Trifluridine and Tipiracil, Irinotecan) | 1 | 27 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Trifluridine and Tipiracil, Irinotecan) | 4 | 27 | 5 |
| other | Edema limbs | General disorders | Treatment (Trifluridine and Tipiracil, Irinotecan) | 2 | 27 | 2 |
| other | Fatigue | General disorders | Treatment (Trifluridine and Tipiracil, Irinotecan) | 9 | 27 | 19 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Treatment (Trifluridine and Tipiracil, Irinotecan) | 1 | 27 | 1 |
| other | Spinal fracture | Injury, poisoning and procedural complications | Treatment (Trifluridine and Tipiracil, Irinotecan) | 1 | 27 | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Trifluridine and Tipiracil, Irinotecan) | 0 | 27 |
| Total, other adverse events | Treatment (Trifluridine and Tipiracil, Irinotecan) | 27 | 27 |
| Total, serious adverse events | Treatment (Trifluridine and Tipiracil, Irinotecan) | 11 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37339254 | 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 |
|---|---|---|---|---|---|
| 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/NCT04072445
GET https://conductscience.org/api/trials/v1/NCT04072445/events?page=2