pancreatic cancer
Conditions
Interventions
Test group:1) Oxaliplatin for injection: dosage 60mg/m2, intravenous infusion for 2 hours or root
According to the clinical practice of the research center
2) HR070803: Dose is 56.5mg/m2, intravenous infusion for 90 minutes (±30min)
3) Calcium folinate: Dose 400mg/m2, complete intravenous infusion within 30 minutes or
According to clinical practice at the research center.
4) 5-fluorouracil: Dose of 2400mg/m2 (infusion for 46-48 h
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old, both male and female 2. pancreatic cancer confirmed by histology or cytology (from pancreatic duct epithelium), clinical records show that it is unresectable locally advanced or metastatic pancreatic cancer (according to the TNM stage of AJCC 8th Edition pancreatic cancer, it is classified as stage III/IV). (The unresectable locally advanced pancreatic cancer is defined as: ? the tumor has no distant metastasis. ? the tumor invades the superior mesenteric artery by more than 180 ° of its circumference.? the tumor invades the abdominal trunk by more than 180 ° of its circumference.? the tumor invades the jejunal branch of superior mesenteric artery.) 3. Have not received systematic anti-tumor therapy in the past. For patients who have received neoadjuvant/adjuvant chemotherapy or radical synchronous radiotherapy and chemotherapy, screening can be conducted if the time from the last chemotherapy to recurrence or progression exceeds 6 months 4. According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not undergone local treatment such as radiotherapy (lesions located within the previous radiotherapy area, if confirmed to have progression, can also be targeted) 5. ECOG: 0-1 6. Expected survival time = 12 weeks 7. The functions of important organs meet the following requirements (no blood components, cell growth factors, leukemic drugs, platelet enhancing drugs, anemia correcting 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 × 109/L. b) Platelets = 85 × 109/L. c) Hemoglobin = 90g/L.d) Serum albumin = 30g/L. e) Total bilirubin = 2.0 × ULN (patients with biliary obstruction, after biliary drainage = 2.5 × ULN), AST and ALT = 3.0 × ULN (liver metastasis patients = 5 × ULN). f) Creatinine clearance rate>60mL/min. g) Activated partial thromboplastin time (APTT) and international standardized 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 treatment range of anticoagulants). 8. Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 12 weeks after the last administration of the study drug For males, surgical sterilization or agreement to use appropriate methods of contraception during observation and within 12 weeks after the last administration of the study medication should be considered. 9. The subjects voluntarily joined this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. pancreatic cancer originating from non pancreatic duct epithelium, including pancreatic neuroendocrine carcinoma Patients with pancreatic acinar cell carcinoma, pancreatic blastoma, and solid pseudopapillary tumors. 2. Patients with central nervous system metastasis. 3. Severe gastrointestinal dysfunction (with bleeding, inflammation, obstruction, or diarrhea greater than grade 1). 4. Existence of grade 3 or 4 peripheral neuropathy. 5. There is uncontrollable pleural effusion, pericardial effusion, or ascites that require drainage. 6. Uncontrolled systemic infections (viruses, bacteria, and fungi). 7. Individuals who have previously been allergic to HR070803, other liposome products, oxaliplatin, 5-fluorouracil, calcium folinate, or any of the aforementioned ingredients. 8. Have received any investigational medication within 4 weeks prior to the first use of the investigational medication. 9. Receive the last dose of anticancer therapy (including radiotherapy) within 4 weeks before the first use of the study drug. 10. Has undergone major surgery within 4 weeks prior to the first use of the study drug. 11. Simultaneously enroll in another clinical study, unless it is an observational (non intervention) clinical study or an intervention clinical study follow-up. 12. The subjects have clinically uncontrolled cardiovascular symptoms or diseases, including but not limited to: (1) NYHA grade II or above heart failure. (2) Unstable angina pectoris. (3) Have experienced myocardial infarction within 1 year. 13. The subject has active hepatitis B (HBV DNA = 2000IU/mL or 104copies/mL), hepatitis C (hepatitis C antibody positive, or HCV-RNA above the detection limit of the analysis method). 14. Has been diagnosed with any other malignant tumor within 5 years prior to the first use of the study drug, except for malignant tumors with low risk of metastasis and death (5-year survival rate>90%), such as fully treated basal cell or squamous cell skin cancer or cervical cancer in situ. 15. Pregnant or lactating women. 16. According to the judgment of the researcher, there are other factors that may cause the subject to be forced to terminate the study midway, such as suffering from other serious diseases (including mental illness) that require concurrent treatment, family or social factors that may affect the safety of the subject or the collection of research data. 17.Other factors that the researchers believe are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;DCR;DoR; | — |
Countries
China
Contacts
Public ContactZHOU JUN
Peking University Cancer Hospital
Outcome results
None listed