Patients with unresectable locally advanced or metastatic pancreatic cancer
Conditions
Interventions
Test group:Irinotecan liposomes (II) combined with oxaliplatin and Tegorgor
Sponsors
The First People's Hospital of Changzhou
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old and =80 years old (calculated on the date of signing the informed consent), gender is not limited; 2. Histological and/or cytological diagnosis of pancreatic cancer (originating from the ductal epithelium of the pancreas) with clinical record of inoperable locally advanced or metastatic pancreatic cancer (stage III/IV based on AJCC 8th Edition of pancreatic cancer TNM stage); 3. Have not received antitumor therapy for the current stage of disease, including chemotherapy, targeting, immunization, surgery (other than stent placement), radiation, or other investigational therapy; 4. If previously received adjuvant chemotherapy, you should ensure that the interval between the last administration and the first administration in this study is more than 6 months, and that the toxic reactions related to adjuvant therapy have recovered (except for the toxicity judged to be =3 months; 8. No major organ dysfunction, that is, the organ function level and relevant laboratory indicators of the subjects within 14 days before the start of the study and treatment must meet the following requirements: (1) Blood routine (no transfusion within 14 days) : white blood cell (WBC) >=3.0×10^9/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=100×10^9/L; Hemoglobin (Hb) >=90 g/L; (2) Blood biochemistry: serum albumin (ALB) >=30 g/L; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =60 mL/min as calculated by Cockcroft-Gault formula; (3) Coagulation function: prothrombin time (PT) or activated partial thromboplastin time (aPTT) =50%); 9. Voluntarily participate and sign informed consent, and be able to comply with research visit plans and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic blastoma, and solid pseudopapillary tumor; 2. Have had malignancies other than pancreatic cancer within 5 years prior to screening (except cured basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and malignancies assessed by investigators as having a low risk of metastasis and risk of death); 3. For patients with known central nervous system metastases and clinically suspected central nervous system metastases, enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the start of study treatment to rule out central axial nervous system metastases; 4. Clinical records show severe gastrointestinal dysfunction (including bleeding, obstruction; CTCAE V5.0 > Grade 2 inflammation; CTCAE V5.0 > Grade 1 diarrhea), 2 weeks before the first dose, after active treatment is still not alleviated; 5. Patients who cannot swallow drugs normally or who eat less than half of their food through mouth; 6. Received the following treatments: (1) CYP3A4, CYP2C8, and UGT1A1 strong suppressor/strong inducer within 14 days prior to initiation of investigational drug therapy; (2) Received the last anti-tumor therapy (including surgery, radiotherapy, etc.) within 4 weeks before starting the study drug therapy, or participated in other drug clinical trials; (3) Prior treatment with irinotecan/irinotecan liposomes. 7. Presence of a serious comorbidibility, active infection, or uncontrolled serious medical condition that prevents treatment with the investigational drug: (1) presence of clinical symptoms or conditions of the heart that are not well controlled, such as: a) New York Heart Association (NYHA) Level 2 or higher heart failure; Unstable angina pectoris; b) Had a myocardial infarction within 6 months; c) supraventricular or ventricular arrhythmias that are clinically significant and require treatment or intervention; (2) Combined with active hepatitis B (HBV DNA >=2000 IU/mL or 10^4copies/mL), hepatitis C (hepatitis C anti-positive); (3) Known to have acquired immune deficiency syndrome (AIDS) or HIV positive, active syphilis infected persons. 8. Known allergy or intolerance to any investigational drug or its excipients; 9. Known contraindications to any investigational drug; 10. Women who are pregnant, breastfeeding or have given birth but refuse to take contraceptive measures; 11. the subjects have other factors that may force the study to be terminated, such as the presence of other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors, affecting the safety of the subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;Overall survival, OS;quality of life;Safety endpoint;Surgical conversion rate; | — |
Countries
China
Contacts
Public ContactChen Xuemin
Changzhou First People's Hospital
Outcome results
None listed