Biliary tract cancers
Conditions
Interventions
Chemo holiday cohort:? GEMOX: a total of 6 courses of treatment. 1 course of treatment was suspended after every 2 courses of treatment. ? Regorafenib: a total of 8 courses of treatment. ? Toripalimab
Conventional chemotherapy cohort:? GEMOX: a total of 6 courses of treatment. ? Regorafenib: a total of 8 courses of treatment. ? Toripalimab: a total of 8 courses of treatment. ? Capecitabine: a total
GEMOX alone cohort:? GEMOX: a total of 6 courses of treatment. ? Capecitabine: a total of 8 courses of treatment.
Sponsors
Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participate in this study voluntarily and sign the informed consent; 2. 18-70 years old; 3. ECOG score of 0; 4. Pathologically diagnosed as biliary tract cancers with negative margins and positive lymph nodes; 5. The function indexes of important organs meet the following requirements: neutrophils >= 1.5*10^9/L; platelets >= 90*10^9/L; hemoglobin >= 9g/dl; serum albumin >= 3.5g/dl; coagulation function: international standardization ( Prothrombin time) ratio (INR) = 60ml/min; 6. Contraception during or 3 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Patients who have received systemic therapy with PD-1 antibody, PD-L1 antibody or CTLA4 antibody, TKI inhibitor, chemotherapy in the past; participated in other clinical trials 30 days previously; 2. Suffering from other malignant tumors in the past or at the same time; 3. Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within one year before treatment; patients with active tuberculosis infection history more than one year before treatment; patients who have not received regular anti-tuberculosis treatment or are still in active tuberculosis; 4. Suffering from active, known or suspected autoimmune disease. Patients with hypothyroidism who only receive hormone replacement therapy or patients who have skin diseases that do not require systemic therapy can be enrolled; 5. Patients have interstitial lung disease or (non-infectious) pneumonia, and need oral or intravenous steroid therapy; 6. Long-term systemic corticosteroids (dose equivalent to >10mg prednisone/day) or any other form of immunosuppressive therapy. Patients using inhaled or topical corticosteroids may be enrolled; 7. Active infection requiring systemic therapy; 8. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive; 9. Significant bleeding symptoms or a clear tendency that appear within 3 months before treatment; 10. Vulnerable groups including mentally ill, cognitively impaired, critically ill patients, minors, pregnant women, lactating women, illiterate, etc.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Adverse events;Quality of life; | — |
Primary
| Measure | Time frame |
|---|---|
| Chemotherapy completion;Recurrence-free survival; | — |
Countries
China
Contacts
Public ContactMingyu Chen
Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed