Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma Therapy (Re-ACT)
5 september 2026 uppdaterad av: Hannes Jansson, Karolinska University Hospital
The Re-ACT Study: Prognostic Evaluation and Systematic Re-Assessment of Chol- Angiocarcinoma Therapy
Prospective observational cohort study including patients with a diagnosis of intrahepatic/perihilar cholangiocarcinoma at the central regional multidisciplinary conference, to assess therapy response, patient-reported quality of life, patient-reported symptoms/experiences and biomarkers.
For patients diagnosed with localized unresectable disease, the study will document the multidisciplinary re-assessment of therapy response.
Studieöversikt
Status
Har inte rekryterat ännu
Studietyp
Observationell
Inskrivning (Beräknad)
900
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Hannes Jansson, MD PhD
- Telefonnummer: +46 8 123 80 000
- E-post: hannes.jansson@regionstockholm.se
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
N/A
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Swedish patients with newly diagnosed intrahepatic- or perihilar cholangiocarcinoma
Beskrivning
Inclusion Criteria:
- Clinical diagnosis of intrahepatic- or perihilar cholangiocarcinoma at the regional multidisciplinary team conference
- For inclusion in the re-assessment arm, a diagnosis of localized, unresectable cholangiocarcinoma at the regional multidisciplinary team conference and clinically evaluated as candidate for tumor-directed medical therapy
Exclusion Criteria:
- Age <18 years
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of conversion to resectability, in patients with localized, unresectable cholangiocarcinoma
Tidsram: At first multidisciplinary re-assessment of therapy response after first-line oncological treatment (typically after 8 cycles, i.e. at an average of approximately 6 months)
|
Change of initial treatment intention
|
At first multidisciplinary re-assessment of therapy response after first-line oncological treatment (typically after 8 cycles, i.e. at an average of approximately 6 months)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recurrence-free survival time
Tidsram: From date of surgery until the date of clinical-radiological recurrence or date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years
|
For patients undergoing curative intent surgery
|
From date of surgery until the date of clinical-radiological recurrence or date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years
|
|
Progression-free survival time
Tidsram: From therapy starting date until date of first documented progression (recurrence, progressive disease acc. to Response Evaluation Criteria in Solid Tumor) or date of death of any cause, assessed at study completion with est. average follow-up 2 years
|
For patients with tumor-directed therapy. Assessment of progressive disease using Response Evaluation Criteria in Solid Tumor (RECIST criteria): Complete Response - disappearance of all target lesions. Partial Response - ≥30% decrease in sum of diameters. Progressive Disease - ≥20% increase in sum of diameters (minimum 5 mm absolute increase) or appearance of new lesions. Stable Disease: neither partial response nor progressive disease |
From therapy starting date until date of first documented progression (recurrence, progressive disease acc. to Response Evaluation Criteria in Solid Tumor) or date of death of any cause, assessed at study completion with est. average follow-up 2 years
|
|
Overall survival time
Tidsram: From date of diagnosis until the date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years
|
From date of diagnosis until the date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years
|
|
|
Patient-reported quality of life according to the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Tidsram: Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion
|
30 item questionnaire with 3 domains: symptoms, functional- and global health status. Items for symptoms and functioning are scored from 1-4 (symptoms - higher score represents higher level of symptomatology; function - higher score represents higher level of functioning). Items for global health status are scored from 1-7 (higher score represents a higher quality of life). Aggregated domain scores are calculated separately, and standardized to a range from 0 to 100, where a high score for symptoms represents a high level of symptomatology; while a high score for function and global health status represents a high level of functioning and a high quality of life. |
Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion
|
|
Patient-reported symptoms/experiences according to the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire in Biliary Tract Cancer (EORTC QLQ-BIL21)
Tidsram: Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion
|
The EORTC QLQ-BIL21 questionnaire consists of 21 items: 3 single-question assessments (side effects, difficulties with biliary drainage, concerns regarding weight loss); and 18 questions aggregated into 5 symptom domains (eating, jaundice, tiredness, pain, anxiety).
Each item is scored from 1-4 (higher score represents higher level of symptomatology).
Symptom scores are transformed to a standardized range from 0 to 100, where a high score represents a high level of symptomatology.
|
Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion
|
|
Longitudinal assessment of circulating tumor DNA plasma concentration
Tidsram: At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion
|
tumor molecules / mL of plasma
|
At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion
|
|
Longitudinal assessment of plasma cytokine profile
Tidsram: At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion
|
Plasma cytokine concentrations (pg/mL)
|
At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion
|
|
Recurrence-free survival rate
Tidsram: At 6, 12, 18 and 24 months from the date of surgery
|
The proportion of patients with curative-intent surgery surviving without a clinical-radiological diagnosis of recurrence
|
At 6, 12, 18 and 24 months from the date of surgery
|
|
Progression-free survival rate
Tidsram: At 6, 12, 18 and 24 months from the starting date of therapy
|
The proportion of patients with tumor-directed therapy surviving without documented progression (recurrence, progressive disease according to Response Evaluation Criteria in Solid Tumor [RECIST criteria]). RECIST criteria: Complete Response - disappearance of all target lesions. Partial Response - ≥30% decrease in sum of diameters. Progressive Disease - ≥20% increase in sum of diameters (minimum 5 mm absolute increase) or appearance of new lesions. Stable Disease: neither partial response nor progressive disease |
At 6, 12, 18 and 24 months from the starting date of therapy
|
Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 september 2029
Avslutad studie (Beräknad)
1 december 2031
Studieregistreringsdatum
Först inskickad
2 september 2026
Först inskickad som uppfyllde QC-kriterierna
5 september 2026
Första postat (Faktisk)
11 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-00080-01/2026-04284-02
Plan för individuella deltagardata (IPD)
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