Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma Therapy (Re-ACT)
5. september 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Observasjonsmessig
Registrering (Antatt)
900
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hannes Jansson, MD PhD
- Telefonnummer: +46 8 123 80 000
- E-post: hannes.jansson@regionstockholm.se
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
N/A
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Swedish patients with newly diagnosed intrahepatic- or perihilar cholangiocarcinoma
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of conversion to resectability, in patients with localized, unresectable cholangiocarcinoma
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence-free survival time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. september 2029
Studiet fullført (Antatt)
1. desember 2031
Datoer for studieregistrering
Først innsendt
2. september 2026
Først innsendt som oppfylte QC-kriteriene
5. september 2026
Først lagt ut (Faktiske)
11. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-00080-01/2026-04284-02
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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