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

• Status: Active, not recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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 < 1.5×ULN, ALT and AST < 2.5×ULN, CREA<1.5×ULN;

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 pressure>140mmHg or diastolic pressure>90mmHg 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 QTc>500ms 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.