BTC
Conditions
Interventions
Treatment group:Radiotherapy combined with NALIRI (irinotecan liposome injection II in combination with 5-FU/LV) and Adebrelimab
Sponsors
Fudan University Affiliated Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Participation in This Study: 1. Patients must voluntarily agree to participate in this study and sign an informed consent form. 2. Age: must be 18 years or older, with no gender restrictions. 3. Patients must have unresectable locally advanced or oligometastatic metastatic biliary tract tumors confirmed by imaging or pathological diagnosis, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; oligometastatic is defined as no more than five metastatic lesions and no more than two metastatic organs, excluding peritoneal carcinomatosis. 4. Patients must have recurrent malignant biliary tract tumors at an advanced stage that have not received systemic treatment, or have recurred more than six months after surgery or adjuvant therapy. 5. ECOG Performance Status (PS): 0-1. 6. Estimated life expectancy must be at least 12 weeks. 7. Major organ functions must be normal, meeting the following requirements within 14 days before starting study treatment: (1) Hematological tests (no blood transfusion, G-CSF, or medication correction within 14 days before screening): a. Hemoglobin [HB] >= 90 g/L; b. Absolute neutrophil count [ANC] >= 1.5×10^9/L; c. Platelet [PLT] >= 80×10^9/L; (2) Biochemical tests must meet the following criteria (no albumin transfusion within 14 days before screening): a. Serum total bilirubin [BIL] 50 ml/min (Cockcroft-Gault formula). For males: Cr clearance rate = ((140-age)×weight)/(72×blood Cr). For females: Cr clearance rate = ((140-age)×weight)/(72×blood Cr) × 0.85; weight unit: kg; blood Cr unit: mg/mL; (3) International normalized ratio [INR] = 2+, a 24-hour urine protein quantification can be performed, and <1.0 g is eligible for enrollment); 8. Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily use appropriate contraception during the observation period and 8 weeks after the last administration of the study drug; for men, they should be surgically sterilized or agree to use appropriate contraception during the observation period and 8 weeks after the last administration of the study drug; 9. Patients with good compliance are expected to follow the treatment plan for efficacy and adverse reaction follow-up visits.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (Patients meeting any of the following conditions are not eligible for this study): 1. Uncontrolled clinical symptoms or diseases of the heart, such as: (1) Class II or above heart failure according to the New York Heart Association (NYHA) criteria or echocardiography: LVEF (left ventricular ejection fraction) 450ms for males, QTc >470ms for females (QTc interval calculated using the Fridericia formula; if QTc is abnormal, it can be measured three times at intervals of 2 minutes, and the average value can be taken). 2. Hypertension that cannot be controlled within the normal range despite antihypertensive medication (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg) (based on the average value of >= 2 blood pressure readings), allowing for the achievement of the above parameters through the use of antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy. 3. Severe gastrointestinal dysfunction (hemorrhage, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1). 4. Clinically symptomatic ascites requiring puncture, drainage, or patients who have undergone ascites drainage within the past 3 months (except for imaging showing a small amount of ascites that can be controlled without clinical symptoms). 5. Abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN), with a tendency to bleed. 6. Thrombosis or embolic events occurred within 6 months before the start of the study treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc. 7. Currently with interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or other lung fibrosis, organizing pneumonia (e.g., cryptogenic organizing pneumonia), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or evidence of active pneumonia on chest CT scan during the screening period or subjects with severely impaired lung function, allowing for radiation pneumonitis in the radiation field: active tuberculosis. 8. Active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaryitis, vasculitis, nephritis): subjects with skin diseases such as vitiligo, psoriasis, alopecia that do not require systemic treatment, controlled type 1 diabetes treated with insulin, or asthma that has been completely relieved in childhood and does not require any intervention in adulthood may be included; asthma patients requiring bronchodilator medical intervention cannot be included. 9. Use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (dose >10mg/day prednisone or other equivalent corticosteroids) within 14 days before signing the informed consent form. 10. Received any of the following treatments: (1) Medications containing strong inhibitors/inducers of CYP3A4, CYP2C8, or UGT1A1 within 2 weeks before the start of treatment; (2) Radiotherapy within 2 weeks before the start of treatment; (3) Major surgery (such as thoracic surger
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DoR;DCR; | — |
Countries
China
Contacts
Public ContactLiu Tianshu
Fudan university, Zhongshan Hospital
Outcome results
None listed