Clinical trial NCT06422156: SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer
Official title: A Prospective, Multicenter, Single Arm Study of SBRT Combined With Nimotuzumab and Mono-chemotherapy in the Treatment of Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced Pancreatic Cancer
Keywords: advanced pancreatic cancer
stereotactic body radiation therapy (SBRT)
Nimotuzumab
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Biotech Pharmaceutical Co., Ltd.
First posted: 2024-05-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: Up to 12 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: Up to 12 months
measure: Objective response rate (ORR)
timeFrame: Up to 12 months
measure: Disease control rate (DCR)
timeFrame: Up to 12 months
measure: Pain relief rate
timeFrame: Up to 12 months
measure: adverse events
timeFrame: Up to 30 days after last administration
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Junjie Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References: