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

NCT06997913 | Enrolling By Invitation DMC

• 1 other identifier: KY20242343-F-1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymph Node Metastasis; Neurovascular Invasion; Pathology Showed R1 Resection

Keywords

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

Outcome Measures

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.

  2 Year

Secondary Outcomes (3)

• 2-year overall survival rate

  2 Year

• Incidence of adverse events

  2 Year

• Completion rate of treatment

  2 Year

Study Arms (1)

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

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.

Adjuvant chemoradiotherapy combined with immunotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients With High-risk resectable Extrahepatic Cholangiocarcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Hengchao Yu: lead

Study Sites (1)

Department of Hepatobiliary Surgery, the First Affiliated Hospital of Air Force Military Medical University

XiAn, Shanxi, 710000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue

MeSH Terms

Conditions

Lymphatic Metastasis; Cholangiocarcinoma

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Lin Wang Professor.Wang, Doctor of Medicine(M.D.)

  Department of Hepatobiliary Surgery, the First Affiliated Hospital of Air Force Military Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 Year
• Access Criteria: All medical workers

Locations

CN (1)