Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma Therapy (Re-ACT)

September 5, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Hannes Jansson, MD PhD
Phone Number: +46 8 123 80 000
Email: hannes.jansson@regionstockholm.se

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Swedish patients with newly diagnosed intrahepatic- or perihilar cholangiocarcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of conversion to resectability, in patients with localized, unresectable cholangiocarcinoma Time Frame: 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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival time Time Frame: 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 Time Frame: 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 Time Frame: 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) Time Frame: 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) Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 5, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)