pancreatic cancer
Conditions
Interventions
Treatment group:Transcatheter arterial chemoembolization (TACE)+tirilizumab+ lenvatinib
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: [1] Histologically or cytologically confirmed unresectable pancreatic ductal adenocarcinoma with hepatic metastases (TNM stage: IV); [2] No prior systemic therapy. *Note: Patients who have received only 1 cycle of prior medication, or who have received oral targeted therapy or chemotherapeutic agents with a cumulative duration of less than 14 days, or who have relapsed more than 6 months after the completion of adjuvant chemotherapy, should be considered for inclusion; [3] No local treatment (i.e., trans-arterial chemoembolisation [TACE], radiotherapy, radioembolisation, or ablation) to the target lesion within 28 days prior to the first dose of study drug; [4] Age >18 years, regardless of sex; [5] ECOG Performance Status score of 0-1; [6] Must have at least one measurable lesion that meets the RECIST 1.1 evaluation criteria]; [7] Women of reproductive age with confirmed non-pregnancy by serum ß-HCG testing. Women of childbearing potential must use appropriate contraception to reduce the risk of pregnancy throughout the study and for 12 weeks after the last dose of investigational product; [8] The patient's organ function tests must be consistent with the following laboratory parameters: Neutrophils >1500/U. Neutrophils > 1500/Ul, haemoglobin > 8.0 gm/dL, platelets > 100,000/uL. creatinine 30 g/L [9] No clinical evidence of portal hypertension with esophageal variceal hemorrhage within 6 months prior to the first dose of study drug. [10] Concomitant bisphosphonate therapy is allowed in patients with bone metastases; [11] Concomitant jaundice must have undergone biliary decompression prior to enrollment; [12] Understand and sign a letter of consent; and able to understand and sign a written informed consent; good compliance is expected. Survival is expected to be more than 3 months.
Exclusion criteria
Exclusion criteria: [1] CNS damage or leptomeningeal disease; [2] Radiotherapy to more than 50% of the bone marrow; [3] Other serious diseases or conditions, including congestive heart failure (NYHA III or IV), unstable angina, heart attack in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, psychiatric disorders, and substance abuse; [4] Known hypersensitivity to the study drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies; [5] Co-infections requiring intravenous antibiotic therapy; [6] Pregnant or breastfeeding women. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the treatment period of this study and for 12 weeks after the last dose of study drug. Sexually active, fertile men who are not using effective contraception themselves if their partner is a woman of childbearing potential; [7] Known neuroendocrine tumors of the pancreas and other non-ductal adenocarcinoma pathology; [8] Previous or concurrent cancers with a primary site or histology completely different from that of pancreatic cancer, with the exception of cervical cancer in situ, previously treated basal cell carcinoma and superficial bladder cancer (Ta, Tis & T1). Any cancer that has been cured >5 years prior to enrollment is eligible; [9] Presence of active immunodeficiency or autoimmune disease and/or history of immunodeficiency or autoimmune disease with potential for relapse; [10] Any disease requiring systemic treatment with corticosteroids (prednisone or equivalent > 10 mg/day) or other immunosuppressive drugs = 14 days prior to the first dose of study drug; [11] Thrombophilia or use of anticoagulants such as warfarin or similar drugs within 6 months prior to the first dose of study drug, or need for antiplatelet medication during the study; [12] Clinically significant haemoptysis, tumour bleeding, or other significant bleeding event within 2 weeks prior to the first dose of study drug; [13] Known history of human immunodeficiency virus infection; [14] Inability to swallow capsules or untreated malabsorption syndrome; [15] Patients with poor compliance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event incidence rate;Disease Control Rate;Overall survival;Progression free survival; | — |
Countries
China
Contacts
Public Contact270 Dong'an Road, Xuhui District, Shanghai, ChinaMeng Zhiqiang/Xie Jing
Fudan University Shanghai Cancer Center
Outcome results
None listed