Advanced pancreatic cancer
Conditions
Interventions
treatment group:Irinotecan liposome (II.) in combination with oxaliplatin and 5-fluorouracil
Sponsors
Beijing Chaoyang Sanhuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, male or female; 2. Histologically or cytologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) with unresectable locally advanced or metastatic pancreatic cancer (stage III/IV according to AJCC 8th edition pancreatic cancer TNM). (Unresectable locally advanced pancreatic cancer is defined as: (1) no distant metastases to the tumor; (2) tumor invasion of superior mesenteric artery more than 180° of circumference; (3) The tumor invades the celiac trunk by more than 180° of the circumference; (4) The tumor invades the jejunal branch of the superior mesenteric artery. ); 3. No prior systemic anti-tumor therapy. For patients who have received neoadjuvant/adjuvant chemotherapy or radical concurrent chemoradiotherapy, the time from the last chemotherapy to recurrence or progression is more than 6 months can be screened; 4. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), at least one measurable lesion, and the measurable lesion should not have received local therapy such as radiotherapy (lesions located in the area of previous radiotherapy, if progression is confirmed, it can also be used as a target lesion); 5. ECOG: 0~1; 6. Expected survival >= 12 weeks; 7. The function of vital organs meets the following requirements (no blood components, cell growth factors, whitening drugs, platelet-raising drugs, anemia correction drugs, etc. are allowed to be used within 14 days before the first use of the study drug); a) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; b) Platelets >= 85 × 10^9/L; c) Hemoglobin >= 90g/L; d) Serum albumin >= 30g/L; e) Total bilirubin 60mL/min; g) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 × ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin, and INR can be screened within the expected therapeutic range of anticoagulants); 8. Women of childbearing potential must have a negative pregnancy test (serum or urine) result within 7 days prior to enrollment and voluntarily use appropriate methods of contraception during the observation period and within 12 weeks after the last administration of study drug; For males, should be surgically sterile or agree to use an appropriate method of contraception during the observation period and for 12 weeks after the last administration of study drug; 9. Subjects voluntarily join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pancreatic cancer originating from non-pancreatic ductal epithelium, including patients with pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic blastoma, solid-pseudopapillary tumor; 2. Patients with central nervous system metastases; 3. Severe gastrointestinal dysfunction (bleeding, inflammation, obstruction or diarrhea greater than grade 1); 4. Presence of grade 3 or 4 peripheral neuropathy; 5. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites that requires drainage; 6. Uncontrolled systemic infections (viral, bacterial, and fungal); 7. Those who have been allergic to irinotecan liposomes, other liposomal products, oxaliplatin, 5-fluorouracil and any of the above ingredients in the past; 8. Receipt of any investigational drug within 4 weeks prior to the first use of the study drug; 9. Received the last dose of anti-cancer therapy (including radiotherapy, etc.) within 4 weeks before the first use of the study drug; 10. Major surgery within 4 weeks prior to the first use of study drug; 11. Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 12. Subject has cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: such as: (1) NYHA grade II or above heart failure; (2) unstable angina; (3) Myocardial infarction within 1 year; 13. Subject has active hepatitis B (HBV DNA >= 2000IU/mL or 104copies/mL), hepatitis C (positive for hepatitis C antibody, or HCV-RNA above the lower limit of detection of the analytical method); 14. Diagnosis of any other malignancy within 5 years prior to the first use of study drug, except for malignancies with low risk of metastasis and mortality (5-year survival rate >90%), except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; 15. Pregnant or lactating women; 16. As judged by the investigator, the subject has other factors that may lead to the forced termination of the study, such as other serious diseases (including mental illnesses) that require concomitant treatment, family or social factors, which may affect the safety of the subjects or the collection of research data; 17. Other factors that, in the opinion of the investigator, are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective relief rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS;Overall survival, OS;Disease control rate, DCR;Duration of relief, DoR; | — |
Countries
China
Contacts
Public ContactSu Aijiang
Beijing Chaoyang Sanhuan Cancer Hospital
Outcome results
None listed