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

Launched by HENGCHAO YU · May 22, 2025

Keywords

ClinConnect Summary

This is a prospective, single-arm study in Xi’an, China that is watching whether adding immunotherapy to standard adjuvant chemoradiotherapy after surgery for high‑risk extrahepatic cholangiocarcinoma helps people stay cancer-free at 2 years. Participants receive a combination of tislelizumab (an immunotherapy drug) with capecitabine (a chemo drug) and radiotherapy after tumor removal. The main goal is to measure the 2-year recurrence-free survival, and researchers plan to enroll about 65 patients over the study period.

Who may be eligible: adults aged 18–70 who had surgery to remove extrahepatic cholangiocarcinoma and have high-risk features (such as certain pathology findings like cancer near the surgical margins or in nearby nerves/blood vessels, or lymph node involvement), with good performance status and normal organ function, and no prior systemic cancer therapy. Exclusions include other active cancers (in most cases), pregnancy, serious infections or autoimmune conditions, and several heart or immune system conditions. If enrolled, you’ll receive tislelizumab every 3 weeks, capecitabine by mouth twice daily on days 1–14 of a 21-day cycle for six cycles, and radiotherapy to the relevant area, for up to about 6 months or longer if allowed. The study will track safety, recurrence-free and overall survival at 2 years, and how often treatment is completed, with oversight to protect participants and share findings with researchers.

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Eligibility criteria

• 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:
• • 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；