Last updated on June 2020

Adjuvant Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Biliary neoplasm | Biliary Tract Cancer | Adenocarcinoma | Urothelial Tract Cancer | Malignant neoplasm of gallbladder | Malignant Adenoma | Gallbladder Disease | Gall Bladder Disorders | Gall Bladder Cancer
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age: 18-70 years;
  2. Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;
  3. Pathology indicates R0 with T2-4 or N1; or R1;
  4. ECOG PS 0-1;
  5. Adequate hematologic, hepatic and renal function: ANC 1.5x10^9/L, Hb 80g/L, PLT 100 x10^9/L, albumin 28g/L, total bilirubin < 1.5ULN, ALT and AST < 2.5ULN, CREA<1.5ULN;
  6. At least 6 months of life expectancy.

Exclusion Criteria:

  1. Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
  2. Received previous anti-cancer therapies;
  3. With purulent, infected or delayed healed wounds;
  4. Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;
  5. Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
  6. Have taken aspirin (325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment;
  7. Uncontrollable hypertension, systolic pressure140mmHg or diastolic pressure90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;
  8. Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc500ms upon screening;
  9. Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
  10. Active tuberculosis, having antituberculosis therapy at present or within 1 year;
  11. Have a known history of prior invasive malignancies within 5 years before enrolment;
  12. Have other uncontrollable comorbidities;
  13. Infection of HIV, known syphilis requiring treatment;
  14. Allergic to chemotherapeutics.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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