NCT07478679尚未招募1 期
Use of Low-Dose RADiotherapy in the Management of Immune Checkpoint- Inhibitor-ArThropathy as an Immune-Related Adverse Event (RADIATE)
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiation therapy
研究概览
简要总结
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which they are receiving single agent or combination immunotherapy or within the last 6 months.
- •Rheumatologist-established diagnosis of new onset CTCAE grade 2-3 immunotherapy-induced inflammatory arthritis or activated osteoarthritis, involving one or more joints (up to 3) including but not limited to hands, shoulders, elbows, hips, knees and ankles.
- •Age ≥ 40 years.
- •ECOG performance status ≤2 (Karnofsky ≥60%).
- •Patients with ability and willingness to sign consent.
排除标准
- •Contraindications to radiation treatment, such as pregnancy, breast-feeding women and active collagen-vascular disease.
- •Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was >1 year prior to consent and/or clear documentation states that the patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to initiation of study treatment.
- •Have not received systemic steroids within the last 3 months for the treatment of immune related adverse events.
- •History of prior autoimmune conditions, or concurrent immune related adverse events requiring systemic immunosuppressants.
- •Estimated life expectancy less than 3 months as assessed by investigators.
- •Any condition at the discretion of investigator that will preclude participation in the study.
- •History of secondary malignancy as assessed by investigators.
- •History of radiation to affected joints as assessed by investigators.
研究组 & 干预措施
Radiation treatment
Experimental
干预措施: Low dose radiation therapy (Radiation)
结局指标
主要结局
Radiation therapy
时间窗: 3 months post enrollment.
To assess the safety and feasibility of administering Low dose radiation therapy (LDRT) in patients with immunotherapy-induced arthritis. Number of patients that experience at least one treatment related Common Terminology Criteria for Adverse Events (CTCAE) grade 4 or 5 side effect.
次要结局
- To examine the use of steroids.(3 months post enrollment.)
- To examine the use of rescue analgesics.(3 months post enrollment.)
- Effectiveness of Radiation in treating immunotherapy-induced arthritis.(3 months post enrollment.)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Combination of High and Low-Dose Radiotherapy With Immune Therapy and TKI in Advanced Colorectal Cancer: A Phase II StudyNCT07467590Daping Hospital and the Research Institute of Surgery of the Third Military Medical University33
招募中
2 期
LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPCNCT07325539Sun Yat-sen University55
招募中
3 期
40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT07328854Ming-Yuan Chen346
招募中
不适用
SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARCNCT07474103Union Hospital, Tongji Medical College, Huazhong University of Science and Technology49
招募中
不适用
Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate CancerNCT07468903Jonsson Comprehensive Cancer Center45