Borderline Resectable Pancreatic Cancer /Locally Advanced Pancreatic Cancer
Conditions
Interventions
Test group:Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin and sequential radiotherapy in Neoadjuvant Therapy
Sponsors
Jingzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: 1. Age =18 years old, male or female; 2: 2. Histologically or cytologically confirmed pancreatic cancer (derived from the ductal epithelium of the pancreas) assessed by the investigator, with clinical records showing borderline resectable and advanced pancreatic cancer. (According to the CSCO Guidelines 2022, critically resectable advanced pancreatic cancer is defined as: (1) a tumor with >180° contact to the portovene-superior mesenteric vein, or =180° contact with irregular venous profile or venous thrombosis, but can be completely resected and safely reconstructed; Tumor contact inferior vena cava; ? (pancreatic head/uncinate process tumor) The tumor contacted the common hepatic artery, but did not involve the abdominal trunk artery or the initiation of the left and right hepatic artery, and could be completely resected and safely reconstructed; Tumor contact with superior mesenteric artery =180°; The tumor contacts mutated arteries (e.g. right accessory hepatic artery, replacement right hepatic artery, replacement common hepatic artery, etc.). (pancreatic body and tail tumor) The tumor contacts the superior mesenteric artery =180°; Tumor contact with abdominal trunk artery =180°; 3: 3. Have not received local and systemic anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy and immunotherapy; 4: 4. According to RECIST 1.1,have at least one measurable lesion ; 5: 5.Eastern Cancer Collaborative Group (ECOG) physical fitness score: 0-1 points; 6: 6. Expected survival =12 weeks; 7: 7. 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 investigational drug); a) Absolute neutrophil count (ANC) =1.5×109/L; b) Platelet =80×109/L; c) Hemoglobin =90g/L; d) Serum albumin =30g/L; e) Total bilirubin =2.0 × ULN (patients with biliary obstruction and biliary drainage =2.5 × ULN), AST and ALT=3.0 × ULN (patients with liver metastasis =5 × ULN); f) Creatinine clearance > 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 intended therapeutic range of anticoagulants); 8: 8. Women of reproductive age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and 12 weeks after the last administration of the study drug; 9: 9. Subjects voluntarily join the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1: 1. Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic blastoma, and solid pseudopapillary tumor; 2: 2. Patients with known central nervous system metastases; 3: 3. Severe gastrointestinal dysfunction (bleeding, inflammation, obstruction, or diarrhea greater than grade 1); 4: 4. Presence of grade 3 or 4 peripheral neuropathy; 5: 5. There is uncontrollable pleural effusion, pericardial effusion or ascites that needs drainage; 6: 6. Uncontrolled systemic infections (viral, bacterial and fungal); 7: 7. People who have been allergic to irinotecan liposomes, other liposome products, oxaliplatin, 5-fluorouracil, calcium folinate or any component of the above products; 8: 8. Received any investigational drug within 4 weeks prior to the first use of the investigational drug; 9: 9. Receiving the last dose of anticancer therapy (including radiotherapy, etc.) within 4 weeks before the first use of the investigational drug; 10: 10. Major surgery within 4 weeks before the first use of the study drug; 11: 11. Enrolling 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: 12. The subject has cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: (1) NYHA class II or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; 13: 13. The subject had active hepatitis B (HBV DNA = 2000IU/mL or 104copies/mL), hepatitis C (hepatitis C antibody positive, or HCV-RNA higher than the lower detection limit of the assay); 14: 14. Have been diagnosed with any other malignancies within 5 years prior to the first use of the investigational drug, except malignancies with a low risk of metastasis and death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; 15: 15. Pregnant or lactating women; 16: 16. In the investigator's judgment, the subject has other factors that may lead to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring combined treatment, family or social factors that may affect the subject's safety or the collection of research data;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month EFS rate;ORR;PFS;DCR;DoR;Overall Survival;AE; | — |
Countries
China
Contacts
Public ContactLi Shuang
Jingzhou First People's Hospital
Outcome results
None listed