Trial · NCT04099888
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
NCT04099888, Phase 2, Terminated, PCI Biotech AS; results first posted 2023-09-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer. Trials, record NCT04099888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04099888
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
- NCT number
- NCT04099888
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- PCI Biotech AS
- Conditions
- Cholangiocarcinoma
- Interventions
- Fimaporfin and Gemcitabine, Gemcitabine/Cisplatin chemotherapy
- First posted
- 2019-09-23
- Last updated
- 2023-09-11
- Results first posted
- 2023-09-11
- Limitations and caveats
- Due to the early termination of this study, no definitive conclusions can be drawn since an insufficient number of participants was recruited. A reduced statistical analysis was conducted.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to 18 months | From date of randomisation to date of objective disease progression or death, whichever comes first (in months) |
| Secondary | Overall Survival (OS) | Up to 24 months | From date of randomisation to date of death from any cause (in months) |
| Secondary | Best Overall Response (BOR) | Up to 18 months | Best response recorded from start of treatment until disease progression/recurrence (according to RECIST 1.1) |
| Secondary | Objective Response Rate (ORR) | Up to 18 months | Proportion of patients with measurable disease at baseline who have at least one visit response with a complete response (CR) or partial response (PR) noted (according to RECIST 1.1) |
| Secondary | Duration of Response (DoR) | Up to 24 months | From first documented tumour response until first documented disease progression, or death in the absence of disease progression (in months) |
| Secondary | Overall Disease Control Rate (DCR) | 6 months and 12 months | Proportion of patients with BOR of CR, PR or stable disease (SD) (according to RECIST 1.1) at or after the first follow-up scan, partial response or complete response |
| Secondary | Change in Tumor Size | Up to 18 months | Best overall percentage change in tumour size from baseline |
| Secondary | Loco-regional Tumour-related Events and Biliary Complications | Up to 12 months | Frequency and severity of loco-regional tumour related events and biliary complications |
| Secondary | Adverse Events (AEs)/Serious Adverse Events (SAEs) | Up to 12 months | Number and proportion of patients with AEs/SAEs |
| Secondary | Area Under the Plasma Concentration Curve (AUC) Was Performed for Patients in Arm A. | Time Frame AUC calculated from time zero to C5-D8 (3 months from the first PCI treatment) | A non-compartmental analysis (NCA) was applied on the data. AUC from time zero to the last measured concentration (AUC 0-t) was initially estimated by the linear trapezoidal method. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 18 months | Modified intent-to-treat (mITT) analysis set (all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline). | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 24 months | Modified intent-to-treat (mITT) analysis set (all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response (BOR) | Up to 18 months | Modified intent-to-treat (mITT) analysis set (all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Up to 18 months | Modified intent-to-treat (mITT) analysis set (all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DoR) | Up to 24 months | Days | NUMBER | |
| SECONDARY | Overall Disease Control Rate (DCR) | 6 months and 12 months | Modified intent-to-treat (mITT) analysis set (all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Tumor Size | Up to 18 months | Only patients with measurable disease at baseline are included in this summary. | Percentage Change in Tumor Size | MEAN |
| SECONDARY | Loco-regional Tumour-related Events and Biliary Complications | Up to 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Events (AEs)/Serious Adverse Events (SAEs) | Up to 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Area Under the Plasma Concentration Curve (AUC) Was Performed for Patients in Arm A. | Time Frame AUC calculated from time zero to C5-D8 (3 months from the first PCI treatment) | AUC was calculated for each single patient and not for the population since the study was terminated and the amount of data was limited. No mean and standard deviation was calculated for the population | (ng/ml)*hrs | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group105
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) | PCI Treatment in Conjunction With Standard of Care (SoC) | 7.29 | 95% Confidence Interval 6.00 to 12.00 | Months | |
| Progression-free Survival (PFS) | Standard of Care (SoC) | 8.08 | 95% Confidence Interval 6.00 to 12.00 | Months | |
| Overall Survival (OS) | PCI Treatment in Conjunction With Standard of Care (SoC) | 12 | Participants | ||
| Overall Survival (OS) | Standard of Care (SoC) | 13 | Participants | ||
| Best Overall Response (BOR) | PCI Treatment in Conjunction With Standard of Care (SoC) | Complete response | 0 | Participants | |
| Best Overall Response (BOR) | Standard of Care (SoC) | Complete response | 0 | Participants | |
| Best Overall Response (BOR) | PCI Treatment in Conjunction With Standard of Care (SoC) | Partial response | 3 | Participants | |
| Best Overall Response (BOR) | Standard of Care (SoC) | Partial response | 3 | Participants | |
| Best Overall Response (BOR) | PCI Treatment in Conjunction With Standard of Care (SoC) | Stable disease | 12 | Participants | |
| Best Overall Response (BOR) | Standard of Care (SoC) | Stable disease | 11 | Participants |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PCI Treatment in Conjunction With Standard of Care (SoC) | 21 | |
| Overall Study | STARTED | Standard of Care (SoC) | 20 | |
| Overall Study | COMPLETED | PCI Treatment in Conjunction With Standard of Care (SoC) | 0 | |
| Overall Study | COMPLETED | Standard of Care (SoC) | 0 | |
| Overall Study | NOT COMPLETED | PCI Treatment in Conjunction With Standard of Care (SoC) | 21 | |
| Overall Study | NOT COMPLETED | Standard of Care (SoC) | 20 |
Source ClinicalTrials.gov
Adverse events82
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 | Gastrointestinal disorders | Gastrointestinal disorders | PCI Treatment in Conjunction With Standard of Care (SoC) | 10 | 18 | 30 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Standard of Care (SoC) | 12 | 16 | 35 |
| other | General disorders and administration site conditions | General disorders | PCI Treatment in Conjunction With Standard of Care (SoC) | 9 | 18 | 13 |
| other | General disorders and administration site conditions | General disorders | Standard of Care (SoC) | 8 | 16 | 13 |
| other | Investigations | Investigations | PCI Treatment in Conjunction With Standard of Care (SoC) | 6 | 18 | 45 |
| other | Investigations | Investigations | Standard of Care (SoC) | 1 | 16 | 10 |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | PCI Treatment in Conjunction With Standard of Care (SoC) | 1 | 18 | 8 |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Standard of Care (SoC) | 3 | 16 | 12 |
| other | Hepatobiliary disorders | Hepatobiliary disorders | PCI Treatment in Conjunction With Standard of Care (SoC) | 4 | 18 | 8 |
| other | Hepatobiliary disorders | Hepatobiliary disorders | Standard of Care (SoC) | 3 | 16 | 6 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PCI Treatment in Conjunction With Standard of Care (SoC) | 7 | 19 |
| Total, all-cause mortality | Standard of Care (SoC) | 2 | 15 |
| Total, other adverse events | PCI Treatment in Conjunction With Standard of Care (SoC) | 18 | 18 |
| Total, other adverse events | Standard of Care (SoC) | 16 | 16 |
| Total, serious adverse events | PCI Treatment in Conjunction With Standard of Care (SoC) | 12 | 18 |
| Total, serious adverse events | Standard of Care (SoC) | 8 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PCI Treatment in Conjunction With Standard of Care (SoC) vs Standard of Care (SoC): Overall Survival (OS) | Trial comparisons |
| PCI Treatment in Conjunction With Standard of Care (SoC) vs Standard of Care (SoC): Adverse Events (AEs)/Serious Adverse Events (SAEs) | Trial comparisons |
| PCI Treatment in Conjunction With Standard of Care (SoC) vs Standard of Care (SoC): Loco-regional Tumour-related Events and Biliary Complications | Trial comparisons |
| PCI Treatment in Conjunction With Standard of Care (SoC) vs Standard of Care (SoC): deaths from any cause | Trial comparisons |
| PCI Treatment in Conjunction With Standard of Care (SoC) vs Standard of Care (SoC): Objective Response Rate (ORR) | Trial comparisons |
| PCI Treatment in Conjunction With Standard of Care (SoC) vs Standard of Care (SoC): 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/NCT04099888
GET https://conductscience.org/api/trials/v1/NCT04099888/results?page=2