Status:
UNKNOWN
Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Biliary Tract Cancer
Extrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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-ris...
Detailed Description
The trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation+immunotherapy group, observation group) after operation. Patients in chemoradiation+immunotherapy ...
Eligibility Criteria
Inclusion
- 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
- 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;
- Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
- Active tuberculosis, having antituberculosis therapy at present or within 1 year;
- Have a known history of prior invasive malignancies within 5 years before enrolment;
- Have other uncontrollable comorbidities;
- Infection of HIV, known syphilis requiring treatment;
- Allergic to chemotherapeutics.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04333927
Start Date
June 1 2020
End Date
June 1 2024
Last Update
June 23 2020
Active Locations (1)
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1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080