Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk Resectable Extrah… (NCT06997913) | Clinical Trial Compass
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Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk Resectable Extrahepatic Cholangiocarcinoma（AICRC）
China10 participantsStarted 2025-03-15
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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);
✕. Have other uncontrollable comorbidities;
✕. Infection of HIV, known syphilis requiring treatment;