A Prospective, Multicenter, Single Arm Study of SBRT Combined With Nimotuzumab and Mono-chemotherapy in the Treatment of Locally Advanced Pancreatic Cancer

M2023639

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).

2024-06-01

2026-06-01

2026-06-01

Not yet recruiting

Early phase I

73

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 73, 'type': 'ESTIMATED'}}

2024-05-20