Locally Advanced Unresectable Pancreatic Cancer
Conditions
Interventions
Locally Advanced Unresectable Pancreatic Cancer:KSD-301 in combination with gemcitabine and albumin-bound paclitaxel
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The age is 18-75 years old , gender is not limited. 2.Signed informed consent has been obtained, and the patient is able to comply with the visit schedule and related procedures specified in the protocol. 3.Histologically or cytologically confirmed locally advanced pancreatic ductal adenocarcinoma. 4.No prior systemic treatment for locally advanced pancreatic cancer. 5. Eastern Cooperative Oncology Group (ECOG) score of 0-1. 6.The estimated survival time is more than 6 months. 7. Adequate organ and bone marrow function, defined as follows: (1)Hematology test: Absolute neutrophil count (ANC) >=1.5×10^9/L; platelet count (PLT) >=100×10^9/L; hemoglobin (HGB) >=90 g/L. No granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red cell transfusion, or platelet transfusion within 14 days prior to the examination. (2) Liver function: Total bilirubin (TBIL) =60 mL/min (calculated using the Cockcroft-Gault formula). (4) Coagulation function: International normalized ratio (INR) =50%. 8. Fertile patients (both male and female) must agree to use a reliable method of contraception (hormonal or barrier methods or abstinence) during the trial and for at least 180 days after the last dose. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
Exclusion criteria
Exclusion criteria: 1.Received (attenuated) live vaccines within 4 weeks prior to enrollment.. 2. Patients who have received unapproved investigational drugs or treatments within 4 weeks before the first dose of chemotherapy. 3.Major surgical procedures (e.g., thoracotomy, laparotomy) within 4 weeks prior to the first dose, or minor surgical procedures (e.g., lymph node dissection) within 2 weeks prior to the first dose. Invasive diagnostic procedures for diagnostic purposes (e.g., biopsy) are excluded. 4.Patients with a history of organ or stem cell transplantation. 5.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 6. Severe cardiovascular disease: (1) Grade >= 3 cardiovascular diseases according to the New York Heart Association (NYHA) classification within 6 months prior to enrollment. (2) Unstable angina or severe arrhythmias requiring medication. (3) Other significant electrocardiogram (ECG) abnormalities, including second-degree type II atrioventricular block, third-degree atrioventricular block, bradycardia (ventricular rate 450 msec for males and > 470 msec for females. (5) Uncontrolled hypertension despite active antihypertensive therapy. Uncontrolled hypertension is defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 110 mmHg measured three times at intervals of at least 10 minutes. 7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Patients with symptoms stabilized for at least 2 weeks after drainage may be eligible. 8. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and increased peripheral blood hepatitis B virus (HBV) DNA titer above the ULN; positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis-specific antibodies. 9. Presence of uncontrolled infectious disease within 4 weeks prior to enrollment. 10. Receiving systemic corticosteroid therapy prior to screening and require long-term systemic corticosteroids during the treatment period (except inhalation or topical application) as judged by the investigator, or received systemic corticosteroid therapy (except inhalation or topical application) within 72 hours prior to administration. 11.Have not recovered to normal or Grade <= 1 from prior treatment-induced AEs prior to enrollment, except alopecia (any grade) and peripheral neuropathy (Grade <=2). 12. Other active malignancies within the past 3 years, except for curable cancers that have been markedly cured, such as basal or squamous cell carcinoma, cervical or breast cancer in situ. 13. Prior history of severe drug allergies or history of penicillin allergy. 14. Substance abuse/addiction. 15. Women who are pregnant or nursing. 16. Other serious medical conditions, including liver disease, kidney disease, neurological/psychiatric disorders, endocrine disorders, hematologic disorders, and immune system disorders, which will render a subject unsuitable for participation in the study as judged by the investigator. 17. Patients who are assessed by the investigator as unable or unwilling to comply with the requirements of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security event;Preliminary efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response reaction; | — |
Countries
China
Contacts
Public ContactXianjun Yu
Fudan University Shanghai Cancer Center
Outcome results
None listed