Intrahepatic CholangiocarcinomaRe-ACTNCT07814586
Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma Therapy
An observational study of Intrahepatic Cholangiocarcinoma and Perihilar Cholangiocarcinoma, run by Karolinska University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma, Perihilar Cholangiocarcinoma
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Swedish patients with newly diagnosed intrahepatic- or perihilar cholangiocarcinoma
Who may be able to join
- 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
Who cannot join
- Age <18 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Medical subject headings
- Cholangiocarcinoma, Klatskin Tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of conversion to resectability, in patients with localized, unresectable cholangiocarcinoma
Change of initial treatment intention
Measured: 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 outcomes (9)
Recurrence-free survival time
For patients undergoing curative intent surgery
Measured: 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
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
Measured: 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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
tumor molecules / mL of plasma
Measured: 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
Plasma cytokine concentrations (pg/mL)
Measured: 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
The proportion of patients with curative-intent surgery surviving without a clinical-radiological diagnosis of recurrence
Measured: At 6, 12, 18 and 24 months from the date of surgery
Progression-free survival rate
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
Measured: At 6, 12, 18 and 24 months from the starting date of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Hannes Jansson, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814586
- Sponsor's protocol ID
- 2026-00080-01/2026-04284-02
- Acronym
- Re-ACT
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Public access may be restricted by applicable laws and regulations that prohibit the release of data that could potentially allow a personal identification.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Re-ACT Study: Prognostic Evaluation and Systematic Re-Assessment of Chol- Angiocarcinoma Therapy
- ClinicalTrials.gov ID
- NCT07814586
- Acronym / sponsor ID
- Re-ACT / 2026-00080-01/2026-04284-02
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Swedish patients with newly diagnosed intrahepatic- or perihilar cholangiocarcinoma
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
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
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
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
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
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
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
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
Recurrence-free survival rate
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided. Public access may be restricted by applicable laws and regulations that prohibit the release of data that could potentially allow a personal identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholangiocarcinoma and Perihilar Cholangiocarcinoma, run by Karolinska University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannes Jansson, MD PhD (+46 8 123 80 000, hannes.jansson@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.