A Phase I/II, Open-label Study to Evaluate the Abscopal Response and Safety of Manganese and Standard-of-care Radiotherapy/ SBRT in Subjects With Metastatic Solid Tumors or Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of subjects with an abscopal response
研究概览
简要总结
Radiotherapy is a regular care for metastatic solid tumors or lymphoma, and it can induce immunogenic death of tumor cells and a stronger immune response. Sometimes, tumor regression would be observed at sites distant to an irradiated field because of the radiotherapy-induced anticancer immune responses, so-called abscopal response. Manganese has been confirmed to activate innate immune and function as anticancer immunoadjuvant in pre-clinical studies. This study is designed to assess the abscopal response and safety of combined therapy of manganese and radiotherapy in patients with metastatic solid tumors or lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically proven metastatic solid tumors or lymphoma.
- •Subjects must have at least two distinct measurable sites of disease (≥1 cm).
- •≥ 18 years old.
- •Life expectancy of at least 6 months.
- •Eastern Cooperative Oncology Group performance status 0-
- •Subjects must have stable or progressing disease to the ongoing systemic therapy.
- •Multiple lines of previous chemo-immunotherapy were permitted.
- •Patients with known brain metastases were included in the trial but brain lesions were not eligible as target or non-target lesions.
- •Adequate organ function.
- •Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
- •Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.
排除标准
- •Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- •Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- •Prior organ allograft.
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- •Subjects with previous or concurrent other malignancies.
研究组 & 干预措施
Manganese plus Radiotherapy
Subject received standard-of-care radiotherapy or stereotactic body radiation therapy (SBRT) to one metastatic site. Manganese inhalation began 1 week after the start of radiotherapy and lasted up to 6 months. The same systemic therapy before the enrollment will be maintained.
干预措施: Manganese Chloride (Drug)
Manganese plus Radiotherapy
Subject received standard-of-care radiotherapy or stereotactic body radiation therapy (SBRT) to one metastatic site. Manganese inhalation began 1 week after the start of radiotherapy and lasted up to 6 months. The same systemic therapy before the enrollment will be maintained.
干预措施: Radiotherapy (Radiation)
Manganese plus Radiotherapy
Subject received standard-of-care radiotherapy or stereotactic body radiation therapy (SBRT) to one metastatic site. Manganese inhalation began 1 week after the start of radiotherapy and lasted up to 6 months. The same systemic therapy before the enrollment will be maintained.
干预措施: Chemo-immunotherapy (Drug)
结局指标
主要结局
Proportion of subjects with an abscopal response
时间窗: 6 months
An abscopal response was defi ned as a decrease in the longest diameter of at least 30% in any measurable (≥1 cm) non-irradiated lesion from baseline.
Number of subjects with treatment-related adverse events (AEs)
时间窗: 12 months
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
次要结局
- Overall survival (OS)(24 months)
- Number of participants with laboratory test abnormalities(12 months)
- Disease control rate (DCR)(12 months)
- Progression-free survival (PFS)(24 months)
研究者
Han weidong
Principal Investigator
Chinese PLA General Hospital