NL-OMON49825招募中2 期
Safety and efficacy of the addition of IMM-101 Heat-Killed Whole Cell Mycobacterium obuense to standard stereotactic radiotherapy in locally advanced pancreatic cancer patients (LAPC-2 trial). - LAPC-2
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically confirmed pancreatic cancer, as indicated by a definite
- •cytology report
- •Tumor considered locally advanced after diagnostic work-up including
- •CT-imaging and diagnostic laparoscopy.
- •Age > 18 years and < 75 years.
- •WHO performance status of 0 or 1.
- •ASA classification I or II.
- •No evidence of metastatic disease.
- •Largest tumor diameter < 7 cm x 7 cm x 7 cm.
- •No direct tumor involvement oft he stomach, colon or small bowel.
- •Normal renal function (Creatinine >= 30 ml/min).
- •Normal liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal).
- •Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and
- •hemoglobin > 5.6 mmol/l).
- •Ability to wear and Actiwatch device on non-dominant arm
- •Written informed consent.
排除标准
- •Previous allergic reaction to any mycobacterial product
- •Prolonged systemic corticosteroid or immunosuppressant medication use
- •Pregnancy
- •Lymph node metastases from primary tumor outside the field of radiation.
- •Second primary malignancy except in situ carcinoma of the cervix, adequately
- •treated non-melanoma skin cancer, or other malignancy treated at least 3 years
- •previously without evidence of recurrence.
- •Pregnancy, breast feeding.
- •Serious concomitant systemic disorders that would compromise the safety of
- •the patient or his/her ability to complete the study, at the discretion of the
- •investigator.
- •An active autoimmune disease that has required systemic treatment in past 2
- •years (i.e. with use of disease modifying agents, corticosteroids or
- •immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
- •physiologic corticosteroid replacement therapy for adrenal or pituitary
- •insufficiency, etc.) is not considered a form of systemic treatment.
- •Diagnosis of immunodeficiency or receiving systemic steroid therapy or any
- •other form of immunosuppressive therapy within 7 days prior to the planned
- •first dose of the study. The use of physiologic doses of corticosteroids may be
- •approved after consultation with the Sponsor.
- •Known history of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies).
- •Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
- •[qualitative] is detected).
- •Live virus vaccine within 30 days of planned start of trial treatment.
- •Use of herbal remedies, including traditional Chinese herbal products (e.g.,
- •mistletoe).
研究者
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