Resectable biliary tract malignancies have a high risk of postoperative recurrence
Conditions
Interventions
group1:Capecitabine, 1250mg/m2 orally, bid, Q3W, d1-14
group2:1 Irinotecan liposome :70mg/m2, IV infusion, Q2W, d1
2LV:400mg/m2, IV infusion, Q2W, d1
35-FU:2400 mg/m2, continuous IV infusion, Q2W, d1-2
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old. 2. Patients with histologically diagnosed and resectable malignant tumors of the biliary tract that have reached R0 resection. 3. Postoperative pathology suggests the following high-risk factors: lymph node positivity, vascular invasion, nerve invasion, etc. 4. I have not received systemic chemotherapy in the past. 5. ECOG score ranges from 0 to 1. 6. Good bone marrow and organ function: Need to simultaneously meet: (1) Neutrophils (ANC) >= 1.5 × 109/L, platelets (PLT) >= 100 × 109/L, hemoglobin (Hb) >= 90g/L, white blood cells (WBC) >= 3.0 × 109/L, albumin (ALB) >= 32 g/L, and no bleeding tendency; (2) Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) = 60 mL/min (calculated according to Cockroft Gault). 7. Expected survival period >= 3 months. 8. Voluntarily participate in this study and sign an informed consent form. If the subject does not have the ability to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to research drugs and their excipients. 2. Known or suspected central nervous system metastasis or lymphatic metastasis. 3. Cannot terminate the use of strong inhibitors or inducers of CYP3A, CYP2C8, and UGT1A1 (such as anticonvulsants [phenytoin, phenobarbital, or carbamazepine], rifampicin, rifampicin, rifampicin, St. John's wort [St. John's Wort], grapefruit juice, clarithromycin, itraconazole, lopinavir, nefazodone, nefinavir, ritonavir, saquinamivir, telaprivir, voriconazole, atazanavir, gefilopinavir, indinavir, etc.) within 2 weeks prior to enrollment. 4. Symptoms and signs of intestinal obstruction exist. 5. Except for cervical carcinoma in situ, uterine carcinoma in situ, and non melanoma skin cancer that have been cured within the past 5 years or currently have other malignant tumors. 6. Except for cervical carcinoma in situ, uterine carcinoma in situ, and non melanoma skin cancer that have been cured within the past 5 years or currently have other malignant tumors. 7. Pregnant or lactating female patients, and patients of childbearing age who refuse to receive contraceptive measures. 8. The researchers believe that patients who are not suitable to participate in this study. 9. Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe adverse events;Adverse events; | — |
Countries
China
Contacts
Public ContactMingyu Chen
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed