SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer

Launched by PEKING UNIVERSITY THIRD HOSPITAL · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with locally advanced pancreatic cancer, which is a type of cancer that cannot be surgically removed. The study is looking at how well a combination of a specific type of radiation therapy called SBRT, along with a drug called Nimotuzumab and a single type of chemotherapy, can work together to improve treatment outcomes. The researchers want to find out if this combination is effective and safe for patients.

To take part in this trial, participants need to be between 18 and 75 years old, have a confirmed diagnosis of pancreatic cancer, and meet certain health criteria. For example, their main tumor should be no larger than 5 centimeters, and they should not have had previous treatments like radiation or chemotherapy. Participants will be closely monitored throughout the study to assess their health and response to the treatment. It's important to note that the trial is not yet recruiting participants, so there will be more information available once it begins.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75 years old, gender unlimited;
• • 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
• • 3. Locally advanced pancreatic cancer (according to the NCCN criteria), unresectable or surgically declined;
• • 4. The maximum diameter of the primary tumor was \< 5.0cm;
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• • 6. No prior radiotherapy (upper abdomen) or tumor systemic therapy;
• • 7. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN;
• • 8. Left ventricular ejection fraction ≥50%;
• • 9. Fertile subjects are willing to take contraceptive measures during the study period;
• • 10. Woman who are breastfeeding during the study period or within 150 days after the last treatment;
• • 11. Survival was expected to be ≥3 months;
• • 12.Good compliance and signed informed consent voluntarily.
• Exclusion Criteria:
• • 1. Tumor invasion of gastrointestinal tract;
• • 2. Woman who are pregnant or breastfeeding;
• • 3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years;
• • 4. History of uncontrolled epilepsy, central nervous system disease, or mental disorder, which may influence the signing of informed consent or affect the patient's adherence;
• • 5.Serious heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more, severe congestive heart failure or severe arrhythmia requiring medical intervention, or a history of myocardial infarction within the past 12 months;
• • 6. Patients requiring immunosuppressive;
• • 7.Accompanied by active infections, or a major hematological, renal, metabolic, gastrointestinal, endocrine, or metabolic disorder determined by the investigator, or other serious uncontrolled concomitant disease;
• • 8. Known allergy to prescription or any component of the prescription used in this study;
• • 9. Immunodeficiency, including HIV infection or other acquired immunodeficiency, or a history of organ transplantation, or other immune-related disorders requiring medical intervention;
• • 10. Patients with acute and chronic tuberculosis infection;
• • 11. Received Chinese herbal medicines or immune-modulators for anti-tumor within 2 weeks prior to initial administration;
• • 12.History of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;
• • 13. Received any other form of immunosuppressive therapy within 7 days prior to the initial of study administration;
• • 14. Participated in other clinical trials within 4 weeks, or received another investigational drugs or investigational device within 4 weeks prior to the initial administration;
• • 15.Other reasons that are not suitable to participate in this study according to the researcher's judgment.