Trial · NCT04099888
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Maximum Observed Concentration (Cmax) Was Performed for Patients in Arm A. | Timepoints for pharmacokinetic (PK) sampling: Day -4 (before, 30m and 4hrs after Amphinex), C1-D1, C1-D8, C2-D8, C3-D8, C4-D8, C4-D18 (before, 30m and 4hrs after Amphinex), C5-D1, and C5-D8 | A non-compartmental analysis (NCA) was applied on the data. |
| Secondary | Time to Cmax (Tmax) Was Performed for Patients in Arm A. | Timepoints for PK sampling: Day -4 (before, 30 min and 4 hours after Amphinex), C1-D1, C1-D8, C2-D8, C3-D8, C4-D8, C4-D18 (before, 30 min and 4 hours after Amphinex) , C5-D1, and C5-D8 | A non-compartmental analysis (NCA) was applied on the data as described by Gabrielsson \& Weiner (Methods in molecular biology, 929:161-180, 2012). |
| Secondary | Health-related Quality of Life (QoL) | Up to 18 months | QoL assessment. Patients select one of four answers to 22 questions ranging from 1 (not at all) to 4 (very much). Lower total scores indicate a more favorable QoL perception than a higher score. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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