Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrah… (NCT04333927) | Clinical Trial Compass
UnknownPhase 2
Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer
China92 participantsStarted 2020-06-01
Plain-language summary
The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age: 18-70 years;
✓. Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;
✓. Pathology indicates R0 with T2-4 or N1; 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;
✓. At least 6 months of life expectancy.
Exclusion criteria
✕. Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
✕. Received previous anti-cancer therapies;
✕. With purulent, infected or delayed healed wounds;
✕. Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;
✕. Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
✕. Have taken aspirin (\>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment;
. 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;