Lymph Node MetastasisAICRCNCT06997913
Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk Resectable Extrahepatic Cholangiocarcinoma（AICRC）
An observational study of Lymph Node Metastasis and Neurovascular Invasion, run by Hengchao Yu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymph Node Metastasis, Neurovascular Invasion, Pathology Showed R1 Resection
- What is being tested?
- Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk resectable Extrahepatic Cholangiocarcinoma（AICRC）
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 30 Dec 2027
- How long will I take part?
- 2 Years
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients With High-risk resectable Extrahepatic Cholangiocarcinoma
Who may be able to join
- Age: 18-70 years;
- Primary resectable extrahepatic cholangiocarcinoma proved by pathology which underwent radical surgery;
- Pathology indicates R0 with N1 or Neurovascular invasion; or R1;
- ECOG PS 0-1;
- 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;
- No anti-tumor treatment before radical resection, including radiotherapy and chemotherapy, targeted therapy and immunotherapy；
- At least 6 months of life expectancy.
Who cannot join
- 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);
- Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
- With purulent, infected or delayed healed wounds;
- Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
- 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;
- 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);
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- Have other uncontrollable comorbidities;
- Infection of HIV, known syphilis requiring treatment;
- Uncontrollable hypertension, systolic pressure>140mmHg or diastolic pressure>90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;
- Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc>500ms upon screening;
- Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
- Active tuberculosis, having antituberculosis therapy at present or within 1 year;
- 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；
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Hepatobiliary Surgery, the First Affiliated Hospital of Air Force Military Medical University
XiAn, Shanxi, 710000
About this study
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:
- 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.
- Capecitabine: 1000 mg/m², twice daily (D1-14), administered every 21 days (Q3W) for a total of 6 treatment cycles.
- Radiotherapy: 50Gy to regional lymph nodes and preoperative tumor bed.
- Being tested
- Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk resectable Extrahepatic Cholangiocarcinoma（AICRC）
- Keywords
- extrahepatic cholangiocarcinoma, high-risk recurrence populations, adjuvant chemoradiotherapy combined with immunotherapy
- Medical subject headings
- Lymphatic Metastasis, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk resectable Extrahepatic Cholangiocarcinoma（AICRC）Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk resectable Extrahepatic Cholangiocarcinoma（AICRC） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Year
Secondary outcomes (3)
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.
Measured: 2 Year
Incidence of adverse events
Measured: 2 Year
Completion rate of treatment
Measured: 2 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start15 Mar 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node MetastasisStudies of the same condition, open and under way.
- 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
- 10 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hengchao Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hengchao Yu, The First Affiliated Hospital of Air Force Medical University
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997913
- Sponsor's protocol ID
- KY20242343-F-1
- Acronym
- AICRC
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The survival data of the Patients With High-risk resectable Extrahepatic Cholangiocarcinoma after treatment
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk Resectable Extrahepatic Cholangiocarcinoma（AICRC）
- ClinicalTrials.gov ID
- NCT06997913
- Acronym / sponsor ID
- AICRC / KY20242343-F-1
- Keywords
- extrahepatic cholangiocarcinoma, high-risk recurrence populations, adjuvant chemoradiotherapy combined with immunotherapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hengchao YuUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 31 May 2025 (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.
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.
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:
- 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.
- Capecitabine: 1000 mg/m², twice daily (D1-14), administered every 21 days (Q3W) for a total of 6 treatment cycles.
- Radiotherapy: 50Gy to regional lymph nodes and preoperative tumor bed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant chemoradiotherapy combined with immunotherapy | – | Combination Product: Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk resectable Extrahepatic Cholangiocarcinoma（AICRC）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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With High-risk resectable Extrahepatic Cholangiocarcinoma
Key inclusion criteria (7 listed)
- Age: 18-70 years;
- Primary resectable extrahepatic cholangiocarcinoma proved by pathology which underwent radical surgery;
- Pathology indicates R0 with N1 or Neurovascular invasion; or R1;
- ECOG PS 0-1;
- 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;
Key exclusion criteria (13 listed)
- 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);
- Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
- With purulent, infected or delayed healed wounds;
- Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant 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. | Combination product | Adjuvant chemoradiotherapy combined with immunotherapy |
Primary outcome
2-year recurrence-free survival rate
Time frame: 2 Year
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.
3 secondary outcomes
2-year overall survival rate
Time frame: 2 Year
Incidence of adverse events
Time frame: 2 Year
Completion rate of treatment
Time frame: 2 Year
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 31 May 2025.
- Individual participant dataSharing planned: Yes. The survival data of the Patients With High-risk resectable Extrahepatic Cholangiocarcinoma after treatment
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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.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymph Node Metastasis and Neurovascular Invasion, run by Hengchao Yu at 1 site in China.
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 7 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival rate (time frame: 2 Year). 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 31 May 2025.