EUCTR2020-003945-13-NL进行中（未招募）1 期
Safety and efficacy of IMM-101 combined with stereotactic radiotherapy in patients with limited MEtastatic PANcreatic Cancer(MEPANC-1) - MEPANC-1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
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 normal).
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
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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