Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk Resectable Extrah… (NCT06997913) | Clinical Trial Compass
By InvitationNot Applicable
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for patients with high-risk features like lymph node spread, neurovascular invasion, or an R1 (incomplete) resection margin — does my pathology report show any of these, and does that make this trial worth discussing as an option for me?
2The trial combines immunotherapy with chemoradiation after surgery, which is a more intensive approach than some standard adjuvant treatments — what additional side effects or risks might I face compared to chemoradiation alone, and is my body currently strong enough to handle that combination?
3The trial is 'enrolling by invitation only' — who decides who gets invited, and is there a way for my care team to find out whether I might be considered for it?
4Since this is a phase 'NA' trial focused on measuring 2-year recurrence-free survival, what does that mean about how much safety and effectiveness data already exists for this specific combination, and how does that uncertainty compare to going with a standard adjuvant treatment plan?
5Given that the trial is measuring outcomes at 2 years, what would the follow-up schedule look like, and how might the time commitment for monitoring visits and treatments fit with my recovery and daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;