NL-OMON54853招募中2 期
Safety and efficacy of IMM-101 combined with stereotactic radiotherapy in patients with limited MEtastatic PANcreatic Cancer (MEPANC-1) - MEPANC-1
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
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 (metastatic) pancreatic cancer, as indicated by a
- •definite cytology/histology report.
- •<=5 hepatic and/or pulmonary metastases in total.
- •The combined diameter of all liver metastases AND the primary tumour or local
- •recurrence in the pancreas is <9 cm.
- •The combined diameter of all pulmonary metastases is <9 cm.
- •CA 19-9 < 1000 IU/mL after completion of chemotherapy.
- •Age > 18 years and < 75 years.
- •WHO performance status of 0-2
- •Tumour volume of the primary tumour <7cmx7cmx7cm. Each diameter must not
- •exceed 7 cm.
- •Adequate renal function (eGFR >= 30 ml/min).
- •Adequate liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times
- •Adequate bone marrow function (WBC > 3.0 x 109/L, platelets > 100 x 109/L
- •and hemoglobin > 5.6 mmol/l).
- •Effective contraceptive methods.
- •Written informed consent.
- •Patients who did not complete at least 8 cycles of FOLFIRINOX due to severe
- •toxicity, will be included in the expansion cohort.
排除标准
- •Metastasis in other organs than the lung and liver.
- •Histopathologically proven extra regional lymph node metastasis.
- •Malignant ascites.
- •Liver function insufficient to tolerate the prescribed dose of radiotherapy.*
- •Child-Pugh Classification grade B/C.
- •Lung function insufficient to tolerate the prescribed dose of radiotherapy.*
- •Diffuse liver metastasis pattern on CT scan.
- •Current or previous treatment with immunotherapeutic drugs.
- •Second primary malignancy except in situ carcinoma of the cervix, adequately
- •treated non-melanoma skin cancer, or other malignancy treated at least 5 years
- •previously to diagnosis of pancreatic cancer and without evidence of recurrence.
- •Pregnancy, breast feeding.
- •An active autoimmune disease that has required systemic treatment in past 2
- •years (i.e. with use of disease modifying agents, corticosteroids or other
- •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.
- •History of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies).
- •Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
- •[qualitative] is detected).
- •Positive PCR test for presence of SARS-CoV-2 during screening stage.
- •Live virus vaccine within 30 days of planned start of trial treatment.
- •Use of herbal remedies, including traditional Chinese herbal products (e.g.,
- •mistletoe).
- •Allergic reaction to M. obuense or had previously received IMM-101.
- •Otherwise deemed unsuitable by the Investigator.
- •*To be determined by the treating radiologist.
研究者
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