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Enrolling by invitationNCT06997913AICRCUpdated May 31, 2025

Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk Resectable Extrahepatic Cholangiocarcinoma(AICRC)

An observational study in Lymph Node Metastasis, Neurovascular Invasion and Pathology Showed R1 Resection, sponsored by Hengchao Yu. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Hengchao Yu · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this prospective, observational study is to investigate whether adjuvant chemoradiotherapy combined with immunotherapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma resection can improve patients' recurrence-free survival. The primary study endpoint of this prospective study is the 2-year recurrence-free survival.

Read the detailed description

This is a single-arm, prospective clinical study designed to evaluate the efficacy and safety of tislelizumab injection combined with capecitabine and radiotherapy as first-line adjuvant therapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma (ECC) resection. The study will enroll patients with ECC who have not received prior systemic therapy. The primary endpoint is the 2-year recurrence-free survival rate (2y-RFS), with a planned enrollment of approximately 65 subjects.

After providing full informed consent, eligible patients will receive treatment with tislelizumab injection combined with capecitabine and radiotherapy. Each study treatment cycle is 3 weeks, and treatment will continue until the criteria for terminating study treatment are met.

Treatment regimen for the treatment group:

  1. Tislelizumab injection: 200 mg via intravenous infusion (D1), administered every 21 days (Q3W), with maintenance treatment for at least half a year or until disease progression.
  2. Capecitabine: 1000 mg/m², twice daily (D1-14), administered every 21 days (Q3W) for a total of 6 treatment cycles.
  3. Radiotherapy: 50Gy to regional lymph nodes and preoperative tumor bed.
02

Conditions studied

  • Lymph Node Metastasis
  • Neurovascular Invasion
  • Pathology Showed R1 Resection

Keywords

  • extrahepatic cholangiocarcinoma
  • high-risk recurrence populations
  • adjuvant chemoradiotherapy combined with immunotherapy
03

In context

Lymphatic Metastasis

248 studies on the registry are indexed under Lymphatic Metastasis; 92 are open to participants now.

This study's planned enrollment of 10 is below the median of 248 across 116 observational studies indexed under Lymphatic Metastasis.

Browse Lymphatic Metastasis studies →

Lead sponsor

This is the only study on the registry with Hengchao Yu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients With High-risk resectable Extrahepatic Cholangiocarcinoma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: 18-70 years;
  2. Primary resectable extrahepatic cholangiocarcinoma proved by pathology which underwent radical surgery;
  3. Pathology indicates R0 with N1 or Neurovascular invasion; or R1;
  4. ECOG PS 0-1;
  5. Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10\^9/L, Hb ≥ 80g/L, PLT ≥ 100 x10\^9/L, albumin ≥ 28g/L, total bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN, CREA\<1.5×ULN;
  6. No anti-tumor treatment before radical resection, including radiotherapy and chemotherapy, targeted therapy and immunotherapy;
  7. At least 6 months of life expectancy.

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of other malignant diseases outside the biliary tract within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically excised carcinoma in situ);
  2. Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
  3. With purulent, infected or delayed healed wounds;
  4. Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
  5. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatments. Known history of primary immunodeficiency. Only patients with positive autoimmune antibodies need to confirm whether there are autoimmune diseases based on the judgment of the investigator;
  6. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 4 weeks before the first administration of the study. Note: Physiological doses of glucocorticoids are allowed (≤10 mg/day prednisone or equivalent drugs);
  7. Have other uncontrollable comorbidities;
  8. Infection of HIV, known syphilis requiring treatment;
  9. Uncontrollable hypertension, systolic pressure>140mmHg or diastolic pressure>90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;
  10. Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc>500ms upon screening;
  11. Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
  12. Active tuberculosis, having antituberculosis therapy at present or within 1 year;
  13. The medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subject from participating in the study, or the investigator believes that it is not suitable for inclusion in the group. The investigator believes that there are other potential risks and is not suitable for participation;
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adjuvant chemoradiotherapy combined with immunotherapy

    This is a single-arm, prospective clinical study designed to evaluate the efficacy and safety of tislelizumab injection combined with capecitabine and radiotherapy as first-line adjuvant therapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma (ECC) resection.

    Combination Product: Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk resectable Extrahepatic Cholangiocarcinoma(AICRC)

Interventions

  • Combination productAdjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk resectable Extrahepatic Cholangiocarcinoma(AICRC)

    The purpose of this prospective, observational study is to investigate whether adjuvant chemoradiotherapy combined with immunotherapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma resection can improve patients' recurrence-free survival. The primary study endpoint of this prospective study is the 2-year recurrence-free survival.

06

What researchers measure

Primary outcomes

  1. 2-year recurrence-free survival rate

    The target population is enrolled and receives postoperative adjuvant therapy according to the study protocol, the recurrence-free survival status of patients will be observed at 2 years.

    Time frame: 2 Year

Secondary outcomes

  1. 2-year overall survival rate

    The target population is enrolled and receives postoperative adjuvant therapy according to the study protocol, the overall survival status of patients will be observed at 2 years.

    Time frame: 2 Year

  2. Incidence of adverse events

    Time frame: 2 Year

  3. Completion rate of treatment

    Time frame: 2 Year

07

Study locations

1 site
  • Department of Hepatobiliary Surgery, the First Affiliated Hospital of Air Force Military Medical University
    XiAn, Shanxi 710000, China
08

References and documents

Individual participant data

Plan to share: Yes — The survival data of the Patients With High-risk resectable Extrahepatic Cholangiocarcinoma after treatment

Supporting information: Study protocol

Time frame: 2 Year

Access criteria: All medical workers

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for May 2026, 14 months after the start.

Of 49 non-industry observational studies under Lymphatic Metastasis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 14 months is below that.

Counting every sponsor, half of 49 studies reached it within 38 months; a quarter within 23 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2025
First posted
May 31, 2025
StartActual
Mar 15, 2025
Primary completionEst.
May 30, 2026
CompletionEst.
Dec 30, 2027
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06997913
Lead sponsor
Hengchao Yu
Responsible party
Hengchao Yu (Professor, The First Affiliated Hospital of Air Force Medicial University) — Sponsor-investigator
First posted
May 31, 2025
Start date
Mar 15, 2025
Primary completion
May 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
May 31, 2025

Study contacts

Lin Wang Professor.Wang, Doctor of Medicine(M.D.)
study chair · Department of Hepatobiliary Surgery, the First Affiliated Hospital of Air Force Military Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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