pancreatic cancer
Conditions
Interventions
Experimental group:Trilaciclib primary prophylaxis for neoadjuvant chemotherapy
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.ECOG score 0-1; 3.Histologically confirmed pancreatic ductal adenocarcinoma, assessed by a multidisciplinary team and imaging, classified as borderline resectable or locally advanced according to the 2023 V2 NCCN Clinical Practice Guidelines for Pancreatic Cancer: (1)Definition of borderline resectable: 1)Tumor contact with the portal vein-superior mesenteric vein (SMV) >180°, or contact 180°. (For pancreatic body/tail tumors)Tumor contact with the superior mesenteric artery or celiac trunk >180°, tumor contact with the celiac trunk infiltrating the abdominal aorta. 4.No use of G-CSF, TPO, IL-11, ESA, iron supplements, platelet transfusion, or blood transfusion within 2 weeks before the screening period; 5.Major organ function must meet the following requirements: (1)Blood routine: absolute neutrophil count (ANC) >= 1.5×10^9/L, platelet count (PLT) >= 90×10^9/L, hemoglobin (Hb) >= 90 g/L; (2)Biochemistry: ALT and AST = 55%; 6.Female patients who have not undergone or do not intend to undergo surgical sterilization must agree to abstain from sexual activity or use effective contraception during the treatment period and for at least 7 months after the last dose of the study treatment; 7.Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.History of antineoplastic therapy for any malignancy. 2.Pancreatic cancers originating from non-ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid pseudopapillary neoplasm patients; 3.Severe gastrointestinal dysfunction (with hemorrhage, obstruction; inflammation > Grade 2; diarrhea > Grade 1); 4.Participants who are unable to accept or tolerate neoadjuvant chemotherapy for various reasons; 5.Underwent major surgery unrelated to pancreatic cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgery. 6.Received treatment with any investigational medicinal product in another clinical study within 4 weeks prior to the start of treatment, except for observational (non-interventional) studies or follow-up periods of interventional clinical studies. 7.Those with a known history of allergy to any component of the regimen. 8.Lactating women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential who are unwilling to use effective contraception throughout the study period and for 7 months after the last dose of investigational medicinal product. 9.Any other circumstances where the investigator deems the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of neutropenia during neoadjuvant chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Completion rate of full neoadjuvant chemotherapy cycles;Incidence of thrombocytopenia during neoadjuvant therapy;incidence rate of infectious serious adverse events;Surgical conversion rate;Frequency and number of chemotherapy dose reductions;Other AE/SAE;incidence rate of post-operational complications;Incidence of febrile neutropenia during neoadjuvant therapy;The incidence of anemia during neoadjuvant therapy; | — |
Countries
China
Contacts
Public ContactWang Xiaoyi
Huashan Hospital, Fudan University
Outcome results
None listed