Irinotecan liposome combined with 5-FU/LV has shown good efficacy and has certain advantages in reducing the adverse reactions of conventional chemotherapy drugs. Adjuvant treatment of high-risk factors after surgery for biliary tract tumors can be further explored and attempted. Therefore, this study intends to conduct an exploratory study comparing oral capecitabine with irinotecan liposome +5-FU/LV for adjuvant therapy in high-risk patients after resection of resectable biliary malignancies, and evaluate the effectiveness and safety of irinotecan liposome +5-FU/LV as adjuvant therapy for high-risk patients after resection of resectable biliary malignancies. So it can provide more treatment options for patients with postoperative adjuvant therapy of biliary tract malignant tumor.
The DFS rate one year after surgery for biliary malignancy was assumed to be 51.4% with a maximum response rate of poor efficacy and 71.4% with a minimum response rate of good efficacy. A two-stage design was adopted with α=0.05 and certainty (1-β) =0.8, and Minimax was adopted. If a response occurs in 7 out of 14 patients or less, treatment options are rejected; In the second phase, if 24 or fewer responses occur in 38 patients, the protocol is rejected. A total of 38 samples were designed in two stages. The 1-year DFS rate was at least 65.8% in the total population of the test and control groups.
Age 18-75 years old.
Patients with histologically confirmed, resectable biliary malignancies with R0 resection.
Postoperative pathology indicated the following risk factors: positive lymph nodes, vascular invasion, nerve invasion and so on.
Has not received systemic chemotherapy before.
Patients allergic to the investigational drug and its excipients.
Known or suspected central nervous system or lymphatic metastasis.
Cannot discontinue use or has not discontinued use of CYP3A, CYP2C8, and UGT1A1 potent depressants or inducers (e.g., anticonvulsants [phenytoin, phenobarbital, or carbamazepine] within 2 weeks prior to enrollment), rifampicin, rifambutin, St.John's Wort, Grapefruit juice, clarithromycin, Itraconazole, Lopinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Terrapivir, voriconazole, Azanavir, Gefilozil, Indinavir, etc.).
There are signs and symptoms of intestinal obstruction.
Parallel
Irinotecan Liposome
Drug②LV: 400mg/m2, intravenous infusion, Q2W, d1; ③5-FU: 2400 mg/m2, continuous intravenous infusion, Q2W, d1-2;
Capecitabine
Drug① Capecitabine, 1250mg/m2 orally, bid, Q3W, d1-14;
one year DFS rate
The percentage of patients free of disease when the disease-free survival is at the 1-year node
Progression free survival
Time from initiation of treatment to first recording of PD or death
Overall survival
The time between the start of treatment and the first recorded death
Disease-free survival
From randomization to the time when the first tumor recurred or metastasized, or when the subject died for any reason
adverse events
Incidence and severity of adverse events in treatment regimens
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Sir Run Run Shaw Hospital
Lead sponsor
Zhejiang Cancer Hospital
Collaborator
RenJi Hospital
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Fujian Provincial Hospital
Collaborator
Ningbo No. 1 Hospital
Collaborator
Shaoxing People's Hospital
Collaborator
Southern Medical University, China
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
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