Trial · NCT04059562
Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma
NCT04059562, Phase 2, Completed, Heinrich-Heine University, Duesseldorf
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma. Trials, record NCT04059562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04059562
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma
- NCT number
- NCT04059562
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Conditions
- Cholangiocarcinoma
- Interventions
- Combination of Lonsurf® and Irinotecan
- First posted
- 2019-08-16
- Last updated
- 2024-03-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median progression free survival (PFS) | through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up) | Median progression free survival (PFS) |
| Secondary | Progression-free survival rate | At 4 months | Progression-free survival rate @ 4 months defined as the proportion of patients with non-progressive disease 4 months after inclusion by intention to treat analysis |
| Secondary | Median overall survival | through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up) | Median overall survival |
| Secondary | Response according to RECIST 1.1 | through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up) | Proportion of patients with an objective response according to RECIST 1.1 |
| Secondary | Safety (type, grade and frequency of Adverse Events (AEs)/Serious Adverse Events (SAEs)) | through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up) | Safety (type, grade and frequency of AEs/SAEs) |
| Secondary | Quality of life - European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-30) | through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up) | Analysis of quality of life (EORTC QLQ-30) |
| Secondary | Quality of life - EuroQol-5Dimensions-3Levels (EQ-5D-5L) questionnaires | through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up) | Analysis of quality of life (EQ-5D-5L questionnaires) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers29
The papers the trial lists on ClinicalTrials.gov.
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/NCT04059562
GET https://conductscience.org/api/trials/v1/NCT04059562/papers?page=2