sbrt combined with nimotuzumab and mono-chemotherapy in locally advanced pancreatic cancer

Conditions: Advanced Pancreatic Cancer

Summary: this is a prospective, multicenter, single arm clinical study. the main purpose of the study is to evaluate the clinical efficacy and safety of sbrt combined with nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (lapc).

this clinical study is designed as a prospective, multicenter, single arm study to evaluate the clinical efficacy and safety of sbrt combined with nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (lapc). all eligible patients will receive sbrt with doses ranging from 35-40 gy in five fractions, intravenous nimotuzumab 400mg weekly or 600mg on day 1 and 8 of a 21-day cycle, and mono-chemotherapy (gemcitabine, s-1 or capecitabine) until disease progression, death, unacceptable toxicity, or consent withdrawal. the main endpoint is progression-free survival (pfs).

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.

Keywords: advanced pancreatic cancer stereotactic body radiation therapy (sbrt) nimotuzumab