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NCT Number: NCT07814586

Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma 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.

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Key information

Conditions

Intrahepatic Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Perihilar Cholangiocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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)

  8. 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

  9. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

The Re-ACT Study: Prognostic Evaluation and Systematic Re-Assessment of Chol- Angiocarcinoma Therapy

Acronym: Re-ACT

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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