pancreatic cancer
Conditions
Interventions
Irinotecan Hydrochloride Liposome Injection(II) combined with 5-fluorouracil/calcium folinate and oxaliplatin treatment group:1) Irinotecan Hydrochloride Liposome Injection(II): the dose was 60mg/m2,
2) 5-fluorouracil: a dose of 2000mg/m2 (46-48 hours of infusion or according to the clinical practice of the research center) intravenous infusion, D1 administration, once every 2 weeks
3) Calcium leucovorin: the dose is 200mg/m2, 30 minutes to complete the intravenous infusion or according to the clinical practice of the research center, D1 administration, once every 2 weeks
4) Oxaliplatin for injection: the dose was 85mg/m2, intravenous infusion for 2h or according to the clinical practice of the research center, D1 administration, once every 2 weeks
Sponsors
Ningbo NO.2 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, male or female; 2. Patients with locally advanced or metastatic pancreatic cancer confirmed histologically or cytologically; 3. According to RECIST 1.1 criteria for the evaluation of solid tumor efficacy, patients with measurable target lesions or non-measurable targets can be treated; 4.ECOG: 0 ~ 1; 5. Expected survival >=12 weeks; 6. The functions of vital organs meet the following requirements (no blood components, cell growth factors, whitening drugs, platelet enhancing drugs, anemia correction drugs, etc., are allowed within 14 days before the first use of the study drug); a) Absolute neutrophil count >=1.5×10^9/L; b) Platelet =85×10^9/L; c) Hemoglobin >=90g/L; d) Serum albumin>=30g/L; e) Total bilirubin 60 mL/min; g) Activated partial thromboplastin time and international Normalized ratio <=1.5× ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin and international Normalized ratio can be screened within the intended therapeutic range of anticoagulants); 7. Fertile female subjects, as well as male subjects whose partners are women of reproductive age, are required to use at least one medically approved contraceptive method (such as an Intrauterine Device, contraceptive pill, or condom) during the study treatment period and for at least 6 months after the last use of any of the study drugs; 8. Subjects voluntarily join the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with central nervous system metastasis; 2. There is uncontrollable pleural effusion, pericardial effusion or ascites that needs drainage; 3. Known allergy to any component of irinotecan liposome II or other liposomes, 5-fluorouracil, oxaliplatin, calcium folinate; 4. Participated in clinical trials of other drugs within 4 weeks before the start of the experimental drug or did not reach the 5 half-lives of the previous experimental drug before administration, whichever is longer; 5. 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; 6. Subjects requiring systemic treatment with corticosteroids (equivalent dose > 10 mg prednisone per day) or other immunosuppressants within 2 weeks prior to initial use of the study drug, except for corticosteroids for local inflammation and prevention of allergy and nausea and vomiting. Other special cases require communication with the researcher. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone replacement at doses > 10mg/ day of prednisone efficacy are permitted; 7. Those who have received anti-tumor vaccine or have received live vaccine within 4 weeks before the first administration of the investigational drug; 8. History of active autoimmune disease, autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except for patients with vitiligo or childhood asthma/allergies that have healed and do not require any intervention as adults; Autoimmune mediated hypothyroidism treated with a steady dose of thyroid replacement hormone; Type 1 diabetes using steady doses of insulin; 9. A history of immunodeficiency, including Human Immunodeficiency Virus testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 10. The subject has cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: (1) New York Heart Association class II or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; 11. Severe infections (Common Terminology Criteria for Adverse Events > Class 2), such as severe pneumonia requiring hospitalization, bacteremia, and infection complications, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging findings indicate active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in cases of prophylactic antibiotic use; 12. History of interstitial lung disease (except radiation pneumonia without hormone therapy) and non-infectious pneumonia; 13. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment; 14. The subject had active hepatitis B (Hepatitis B Virus Deoxyribonucleic Acid>=2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive, or Hepatitis C Virus Ribonucleic Acid ab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Duration of remission;Disease control rate;Safety metrics; | — |
Countries
China
Contacts
Public ContactChen Yunjie
Ningbo Second Hospital
Outcome results
None listed