Biliary tract cancers
Conditions
Interventions
Chemo holiday cohort:None
Conventional chemotherapy cohort:None
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 the study voluntarily and sign the informed consent; 2. Aged 18-70 years; 3. ECOG score is 0; 4. Postoperative pathological diagnosis was cholangiocarcinoma, with negative incisal margin and positive lymph nodes; 5. Functional indexes of vital organs meet the following requirements: (1) Neutrophils >=1.5*10^9/L; Platelet >=90*10^9/L; Hemoglobin >=9g/dl; Serum albumin >=3.5g/dl; (2) Coagulation function: International standardized (prothrombin time) ratio (INR) =60ml/min; 6. Use contraception during or for 3 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received systematic treatment with PD1 antibody, PDL1 antibody or CTLA4 antibody, TKI inhibitor or chemotherapy; Participated in other clinical trials 30 days prior to screening; 2. Previous or concurrent suffering from other malignant tumors; 3. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to treatment; Have a history of active tuberculosis infection more than 1 year before treatment, have not received regular anti-tuberculosis therapy or have active tuberculosis; 4. Have an active, known, or suspected autoimmune disease. Patients with hypothyroidism requiring hormone replacement therapy and skin conditions requiring no systemic therapy are eligible; 5. Prior interstitial lung disease, or (non-infectious) pneumonia requiring oral or intravenous steroid hormone therapy; 6. Long-term systemic sex hormone (dose equivalent to >10mg prednisone/day) or any other form of immunosuppressive therapy is required. Patients on inhalation or topical corticosteroids may be enrolled; 7. Active infections requiring systemic treatment; 8. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive; 9. Bleeding symptoms of significant clinical significance or definite tendency to appear within 3 months prior to treatment; 10. Vulnerable groups, including persons with mental illness, persons with cognitive impairment, critically ill patients, minors, pregnant and lactating women, illiterates, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chemotherapy completion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival;Overall survival;Adverse events;Quality of life; | — |
Countries
China
Contacts
Public ContactChen Mingyu
Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed