Pancreatic cancer
Conditions
Interventions
Experimental group:Irinotecan liposomes were injected intravenously and Teggio was taken orally
Sponsors
Department of Integrative Medicine, Affiliated Cancer Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: [1] Histologically or cytologically confirmed unresectable metastatic pancreatic ductal adenocarcinoma (TNM stage IV), limited to patients with advanced liver metastases; [2] Previously received gemcitabine-based systemic therapy; [3] No local treatment (i.e., transarterial chemoembolization [TACE], radiotherapy, radiation embolization, or ablation) was received within 21 days prior to the first administration of the investigational drug; [4] Over 18 years of age, regardless of gender; [5]ECOG physical status score 0-1; [6] There must be at least one measurable metastatic lesion of the liver that meets the RECIST1.1 evaluation criteria; [7] Women of childbearing age who were tested for serum beta-HCG were not pregnant. Throughout the study period and within 12 weeks after the final administration of the study product, women of childbearing age should use appropriate methods of contraception to reduce the risk of pregnancy; [8] The patient's organ function tests must meet the following laboratory criteria: 1.Neutrophils (ANC) =1.5×10^9/L, platelets (PLT) =100×10^9/L, hemoglobin (Hb) =90g/L, white blood cells (WBC) =3.0×10^9/L, albumin (ALB) =32 g/L, and no bleeding tendency; 2. AST, ALT and alkaline phosphatase (ALP) were all =2.5× upper limit of normal range (ULN), and =5×ULN when liver metastases occurred; Total bilirubin =1.5×ULN; 3.Serum creatinine (Cr) =1.5×ULN or creatinine clearance =60 ml/min (calculated according to Cockroft-Gault) [9] To study the clinical evidence of no portal hypertension with esophagogastric variceal bleeding within 6 months before the first administration of the drug; [10] Patients with bone metastases are allowed to receive simultaneous bisphosphonate therapy; [11] Patients with jaundice must undergo biliary drainage decompression before admission, with total bilirubin =2.5×ULN; [12] Able to understand and sign written informed consent; Compliance is expected to be good. [13] Those with an expected survival of more than 3 months.
Exclusion criteria
Exclusion criteria: [1] Prior systemic therapy with irinotecan or irinotecan liposomes, ticeo, capecitabine regimens (5-FU and/or ratitrexel are permitted); [2] Central nervous system damage or pia meningeal disease; [3] More than 50% of bone marrow received radiation therapy. [4] Other serious diseases or conditions, including congestive heart failure (New York Heart Association Grade III or IV), unstable angina, heart attack in the past 6 months, severe arrhythmia, QT interval prolongation, active HIV infection or HIV disease, mental disorders, substance abuse, etc.; [5] Known allergy to the investigational drug or any excipients thereof; Or had a severe allergic reaction to another monoclonal antibody [6] Patients with co-infection requiring intravenous antibiotic treatment; [7] Pregnant or breastfeeding women. Women of reproductive age who were unwilling or unable to use an acceptable method of contraception throughout the duration of treatment in this trial and within 12 weeks after the last administration of the study drug. If the partner is a woman of childbearing age, a sexually active, fertile man who does not use effective contraception himself; [8] Known pathological types of pancreatic neuroendocrine tumors and other non-ductal adenocarcinomas; [9] Past or concurrent cancers with a primary focus or histologically distinct from pancreatic cancer, except cervical carcinoma in situ, previously treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cure prior to inclusion 5 years of cancer were allowed to enroll; [10] The presence of any active immune deficiency or autoimmune disease and/or a history of any immune deficiency or autoimmune disease that may recur; [11] Corticosteroids (prednisone or equivalent > 10 mg/ day) or other immunosuppressive drugs for systemic treatment of any disease; [12] Thrombotic disease or the use of anticoagulants such as warfarin or similar drugs within 6 months prior to the first administration of the study, or the use of antiplatelet drugs during the study; [13] Clinically significant hemoptysis, tumor hemorrhage, or other significant bleeding events occurred within 2 weeks before the first administration of the study drug; [14] There is a known history of human immunodeficiency virus infection [15] Inability to swallow capsules or untreated malabsorption syndrome; [16] The use of potent depressants or inducers of CYP3A, CYP2C8, and UGT1A1 (anticonvulsants [phenytoin, phenobarbital, or carbamazepine], rifampicin, rifambutin, St.John's.) could not be discontinued or were not discontinued within 2 weeks prior to enrollment Wort], grapefruit juice, clarithromycin, itraconazole, Lopinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Terrapivir, voriconazole, Azanavir, Gefilozil, indinavir, etc.); [17] The presence of intestinal obstruction or the presence of signs and symptoms of intestinal obstruction;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression free survival;Overall survival;Adverse event incidence rate; | — |
Countries
China
Contacts
Public ContactMeng Zhiqiang
Department of Integrative Medicine, Affiliated Cancer Hospital of Fudan University
Outcome results
None listed