combination of radiotherapy with anti-pd-1 antibody for unresectable biliary tract cancer

Conditions: Biliary Tract Cancer; Radiotherapy; Immunotherapy

Summary: the study is a single-arm, phase ii trial. the purpose is to investigate both the efficacy and safety of radiotherapy combined with anti-pd-1 antibody in unresectable biliary tract cancer patients.

the trial will recruit 36 patients, and they will undergo radiotherapy plus anti-pd-1 antibody. patients will receive conventional intensity-modulated radiotherapy or stereotactic body radiation therapy first for a total dose more than 45gy. camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 75 years old; 2. histopathologically confirmed unresectable primary or initial postoperative recurrent btc without distant metastasis; 3. no previous radiotherapy or systemic therapy; 4. adequate volume of the uninvolved liver (larger than 700 ml); 5. at least one measurable lesion based on response evaluation criteria in solid tumors 1.1 criteria; 6. eastern cooperative oncology group performance status score of 0 or 1; 7. adequate hematologic (absolute neutrophil count ≥ 1.5x109/l, hemoglobin concentration ≥ 90g/l, platelet count ≥ 100 x109/l), hepatic (albumin ≥ 28 g/l, total bilirubin \< 1.5 times the upper limit of normal (uln), alanine aminotransferase and aspartate aminotransferase \< 5×uln) and renal function (serum creatine \< 1.5×uln, creatinine clearance rate ≥ 45ml/min); 8. life expectancy of at least 12 weeks. exclusion criteria: 1. have acute or chronic active hepatitis b or c, hbv-dna\>2000iu/ml or 104 copy/ml; hcv-rna\>103 copy/ml; both hbsag and hcv antibody are positive. if the related results become lower than above standards after anti-viral treatment, the patients are qualified for enrolment; 2. have metastasis in extrahepatic distant organs including lung, central nervous system, bone and etc. or extrahepatic lymph node metastasis beyond abdomen; 3. have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months; 4. have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis; 5. have taken aspirin (\>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment; 6. uncontrollable hypertension, systolic pressure\>140mmhg or diastolic pressure\>90mmhg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy; 7. symptomatic congestive heart failure (nyha class ii-iv). symptomatic or badly-controlled arrhythmia. congenital long qt syndrome or modified qtc\>500ms upon screening; 8. have active autoimmune diseases that require systemic treatment within 2 years before enrolment; 9. active tuberculosis, having antituberculosis therapy at present or within 1 year; 10. have a known history of prior invasive malignancies within 5 years before enrolment; 11. pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial; 12. have other uncontrollable comorbidities; 13. infection of hiv, known syphilis requiring treatment; 14. allergic to elements of camrelizumab.