Trial · NCT04163900
Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer
NCT04163900, Phase 3, Terminated, NuCana plc; results first posted 2023-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer. Trials, record NCT04163900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04163900
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer
- NCT number
- NCT04163900
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 773 participants, actual
- Lead sponsor
- NuCana plc
- Conditions
- Biliary Tract Cancer
- Interventions
- NUC-1031, Gemcitabine, Cisplatin
- First posted
- 2019-11-15
- Last updated
- 2023-05-24
- Other registries' IDs
- eudract:2019-001025-28
- Results first posted
- 2023-05-24
- Limitations and caveats
At Interim Analysis 1, the futility boundary for OS was crossed and the study was closed on 02 Mar 2022. Following study closure, data from the 05 April 2022 final data cut-off (30 day follow-up post the last patient last visit) were analysed. In general, the analyses performed on this final database were those that were scheduled to take place at Interim Analysis 2. However, any p-values or CIs obtained are only viewed as descriptive as the study was stopped for futility.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Evaluated at Screening (baseline) then every 9 weeks from treatment start (C1D1), or every 12 weeks if treatment is stopped with no evidence of progression, until disease progression or death from any cause up to the end of study, an average of 6 months. | Percentage of patients achieving a confirmed complete response (CR) or partial response (PR) to treatment as assessed by blinded independent review according to RECIST v1.1 criteria. ORR = patients with CR + patients with PR, where" CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters This outcome was assessed in the population of patients with measurable disease at baseline who were also randomized ≥28 weeks before the data cut-off (ITTMD28). Patients were to receive a confirmatory scan 28-42 days after response is first observed. |
| Primary | Overall Survival (OS) | From the date of randomization until the date of death from any cause, assessed up to 12 months on average | The median time, in months, from the date of randomization to the date of death from any cause. For patients who were alive at the time of a data cut-off or were permanently lost to follow up, duration of OS was censored at the date at which they were last known to be alive. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Evaluated at Screening (baseline) then every 9 weeks from treatment start (C1D1), or every 12 weeks if treatment is stopped with no evidence of progression, until disease progression or death from any cause up to the end of study, an average of 6 months. | Intent-to-treat with measurable disease at baseline randomized ≥28 weeks before the data cut-off (ITTMD28) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Survival (OS) | From the date of randomization until the date of death from any cause, assessed up to 12 months on average | Intent-to-treat | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | A - NUC-1031 and Cisplatin | 53 | Participants | ||
| Objective Response Rate (ORR) | B - Gemcitabine and Cisplatin | 34 | Participants | ||
| Overall Survival (OS) | A - NUC-1031 and Cisplatin | 9.2 | 95% Confidence Interval 8.3 to 10.4 | Months | |
| Overall Survival (OS) | B - Gemcitabine and Cisplatin | 12.6 | 95% Confidence Interval 11.0 to 15.1 | Months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A - NUC-1031 and Cisplatin | 388 | |
| Overall Study | STARTED | B - Gemcitabine and Cisplatin | 385 | |
| Overall Study | Received Study Treatment (Safety Population) | A - NUC-1031 and Cisplatin | 383 | |
| Overall Study | Received Study Treatment (Safety Population) | B - Gemcitabine and Cisplatin | 378 | |
| Overall Study | COMPLETED | A - NUC-1031 and Cisplatin | 0 | |
| Overall Study | COMPLETED | B - Gemcitabine and Cisplatin | 0 | |
| Overall Study | NOT COMPLETED | A - NUC-1031 and Cisplatin | 388 | |
| Overall Study | NOT COMPLETED | B - Gemcitabine and Cisplatin | 385 |
Source ClinicalTrials.gov
Adverse events472
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 | Nausea | Gastrointestinal disorders | A - NUC-1031 and Cisplatin | 167 | 383 | |
| other | Nausea | Gastrointestinal disorders | B - Gemcitabine and Cisplatin | 142 | 378 | |
| other | Alanine aminotransferase increased | Investigations | A - NUC-1031 and Cisplatin | 142 | 383 | |
| other | Alanine aminotransferase increased | Investigations | B - Gemcitabine and Cisplatin | 62 | 378 | |
| other | Fatigue | General disorders | A - NUC-1031 and Cisplatin | 139 | 383 | |
| other | Fatigue | General disorders | B - Gemcitabine and Cisplatin | 114 | 378 | |
| other | Aspartate aminotransferase increased | Investigations | A - NUC-1031 and Cisplatin | 121 | 383 | |
| other | Aspartate aminotransferase increased | Investigations | B - Gemcitabine and Cisplatin | 57 | 378 | |
| other | Constipation | Gastrointestinal disorders | A - NUC-1031 and Cisplatin | 105 | 383 | |
| other | Constipation | Gastrointestinal disorders | B - Gemcitabine and Cisplatin | 102 | 378 |
1 to 10 of 472Source ClinicalTrials.gov
See all 472 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A - NUC-1031 and Cisplatin | 188 | 388 |
| Total, all-cause mortality | B - Gemcitabine and Cisplatin | 135 | 385 |
| Total, other adverse events | A - NUC-1031 and Cisplatin | 370 | 383 |
| Total, other adverse events | B - Gemcitabine and Cisplatin | 369 | 378 |
| Total, serious adverse events | A - NUC-1031 and Cisplatin | 175 | 383 |
| Total, serious adverse events | B - Gemcitabine and Cisplatin | 126 | 378 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A - NUC-1031 and Cisplatin vs B - Gemcitabine and Cisplatin: Objective Response Rate (ORR) | Trial comparisons |
| A - NUC-1031 and Cisplatin vs B - Gemcitabine and Cisplatin: deaths from any cause | Trial comparisons |
| A - NUC-1031 and Cisplatin vs B - Gemcitabine and 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/NCT04163900
GET https://conductscience.org/api/trials/v1/NCT04163900/events?page=2