Pancreatic cancer
Conditions
Interventions
Experimental group:Combination therapy of autologous NK cells with cetuximab beta and the NALIRIFOX regimen
Control group:The NALIRIFOX regimen
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, and =3 months; 7. If laboratory abnormalities do not meet the following criteria, one review within one week is allowed, and if they still do not meet the criteria, screening failure is considered: blood routine (no blood transfusion, platelet transfusion, growth factor support therapy, except recombinant erythropoietin within 7 days before testing) : Neutrophil count (ANC) >=1.5×10^9/L (1500 /mm^3), platelet count >=100×10^9/L (100,000/mm^3), hemoglobin (Hgb) >=9.0 g/dL (90g/L); Liver function tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =50 mL/min; Coagulation function test: prothrombin time and partial thromboplastin time <=1.5×ULN. 8. Biliary obstruction patients with stent placement and bilirubin meeting the inclusion criteria at screening can be included; 9. The main organ functions were normal, and there were no severe abnormal functions of blood, heart, lung, liver, kidney, bone marrow and immunodeficiency patients; 10. Female study participants of reproductive age or male study participants with a female sexual partner of reproductive age were required to use an effective contraceptive method throughout the treatment period and for 180 days after the treatment period; 11. Fully understand the study and voluntarily sign the informed consent, and can follow the requirements of the study protocol to complete all the trial procedures, good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to any component of the study treatment. 2.Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or clinically significant (e.g., active) cardiovascular or cerebrovascular diseases, such as cerebrovascular accident (within 6 months prior to signing the main ICF), myocardial infarction (within 6 months prior to signing the main ICF), unstable angina, congestive heart failure classified as New York Heart Association (NYHA) Class II or higher, or severe arrhythmia not controlled by medication or potentially affecting the study treatment; electrocardiogram (ECG) showing clinically significant abnormalities in three consecutive readings (each taken at least 5 minutes apart) or average QTcF >=450 ms (>=480 ms for females). 3.Clinically uncontrolled pleural effusion or ascites (patients who do not require drainage or who have no significant increase in effusion for 3 days after stopping drainage may be enrolled). 4.Significant malnutrition, as determined by the investigator, or ongoing requirement for intravenous nutritional support at screening. 5.Active or severe autoimmune diseases; acquired or congenital immunodeficiency disorders; history of organ transplantation. 6.History of another primary malignancy, except for malignancies with complete remission for at least 2 years prior to enrollment and requiring no additional treatment during the study; adequately treated non-melanoma skin cancer or malignant lentigo with no evidence of recurrence; adequately treated carcinoma in situ with no evidence of recurrence. 7.Any uncontrolled clinical problems (e.g., severe neurological, respiratory, cardiovascular, cerebrovascular, or other systemic diseases). 8.Evidence of central nervous system metastases at baseline. 9.History of significant neurological or psychiatric disorders, including epilepsy or dementia. 10.Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or worse cirrhosis. 11.Systemic active infection requiring treatment, including but not limited to active tuberculosis; known HIV-positive, syphilis spiral-positive participants; or clinically active hepatitis A, B, or C (including carriers) should be excluded. 12.Planning for pregnancy or unwillingness to use reliable contraceptive methods during the trial and for 3 months after the last dose. 13.Prior therapies: (1) Previous systemic therapy for locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma. However, patients who received neoadjuvant/adjuvant chemotherapy are eligible if disease progression occurred more than 6 months after the last dose of neoadjuvant/adjuvant chemotherapy. (2) Previous radiotherapy for locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma, with toxicity not recovered to baseline within 2 weeks prior to screening. (3) Previous immune cell therapy, including lymphokine-activated killer (LAK) cells, natural killer (NK) cells, dendritic cells (DC), cytokine-induced killer (CIK) cells, cytotoxic T lymphocytes (CTL), or other types of immune cell therapy. (4) History of bone marrow or organ transplantation, or hematopoietic stem cell transplantation. (5) Systemic treatment with Chinese herbal medicine or herbal products with anti-tumor indications or immunomodulatory effects (including thymosin, interferon, interleukin, etc.) within 2 weeks prior to screening. (6) Whole blood or component transfusion, or treatment with any grow
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;Serious Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-Free Survival;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactRen He
The Affiliated Hospital of Qingdao University
Outcome results
None listed