Comparison · NCT04099888-ea4524e0
PCI Treatment in Conjunction With Standard of Care (SoC) vs Standard of Care (SoC): Objective Response Rate (ORR)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. PCI Treatment in Conjunction With Standard of Care (SoC) vs Standard of Care (SoC): Objective Response Rate (ORR). Trial comparisons, record NCT04099888-ea4524e0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04099888-ea4524e0
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.158 | 0.0552 | 0.376 | wilson | |
| Risk in group 2 | 0.2 | 0.0705 | 0.452 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0421 | -0.314 | 0.211 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.789 | 0.185 | 3.37 | log | |
| Odds ratio, group 1 over group 2 | 0.75 | 0.128 | 4.39 | log | |
| Number needed to treat, for one fewer participant with the outcome on PCI Treatment in Conjunction With Standard of Care (SoC) than on Standard of Care (SoC) | 23.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PCI Treatment in Conjunction With Standard of Care (SoC) | Arm A: Fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by gemcitabine/cisplatin chemotherapy~Fimaporfin and Gemcitabine: PCI treatment consists of IV administration of Amphinex solution for injection (investigational product) at 0.22 mg/kg dose of fimaporfin, followed 4 days later by a standard dose of gemcitabine infusion (1000 mg/m²) and intraluminal laser light application. Up to 2 PCI treatments will be given.~Gemcitabine/Cisplatin chemotherapy: Up to 8 cycles of gemcitabine/cisplatin combination chemotherapy will be administered. | 3 | 19 | OG000 |
| Group 2 | Standard of Care (SoC) | Arm B: Gemcitabine/cisplatin chemotherapy~Gemcitabine/Cisplatin chemotherapy: Up to 8 cycles of gemcitabine/cisplatin combination chemotherapy will be administered. | 3 | 15 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Objective Response Rate (ORR)
- Description
- 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)
- Time frame
- Up to 18 months
- Population
- 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).
Source ClinicalTrials.gov
Trial
- Title
- PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
- NCT number
- NCT04099888
- Phases
- PHASE2
- Conditions
- Cholangiocarcinoma
- Interventions
- Fimaporfin and Gemcitabine, Gemcitabine/Cisplatin chemotherapy
- Lead sponsor
- PCI Biotech AS
- Results first posted
- 2023-09-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04099888?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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