NCT05755009招募中不适用
High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor: A Single-arm, Single-center, Phase II Trial
Jiangxi Provincial Cancer Hospital2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of high- and low-dose radiotherapy (HD-RT/LD-RT) combined with envafolimab (I) in the treatment of metastatic solid tumors that have failed first-line immunotherapy or above.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with metastasis (including recurrence) solid tumors and failure with first-line or above immunotherapy (PD-1/PD-L1/CTLA-4 inhibitors), and no subsequent standard treatment regimen.
- •Previous histopathologic confirmation of malignancy.
- •Tumor diameter > 5 cm or the number of metastases is 6-15 (at least one measurable lesion, bone metastases are not used as target lesions), not suitable for conventional radiotherapy, surgery, radiofrequency ablation, and other treatments.
- •Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months.
- •During the study, they are willing to follow the arrangement and not use other systemic anti-tumor drugs such as chemotherapy, targeted, Chinese herbal medicine, and proprietary Chinese medicine.
- •18-70 years old, no gender limit.
排除标准
- •Patients with glioma or brain metastases.
- •Those with a history of severe immediate allergy to the drugs used in this study.
- •Suffered from other malignant tumors other than nasopharyngeal carcinoma within 5 years (except for tumors with an expected 5-year OS>90%, such as non-melanoma skin cancer or pre-invasive cervical cancer).
- •Cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc.
- •Any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction <50% must adopt an optimized and stable medical plan determined by the treating doctor. If appropriate, you can consult a cardiologist.
- •Received systemic anti-tumor therapy such as targeted therapy and biological drug therapy within 3 weeks before the first dose; Have received any Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 7 days before the first dose.
结局指标
主要结局
Objective response rate (ORR)
时间窗: 6 months
the proportion of patients achieving the optimal overall remission (complete or partial remission)
次要结局
- Progression-free survival (PFS)(two year)
- Overall survival (OS)(two years)
- Safety evaluation(two years)
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
2 期
Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT06468644Fujian Cancer Hospital60
招募中
2 期
Low-dose Radiation Combined With Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT06446726Sichuan University30
Unknown
1 期
Efficacy and Safety of Radiotherapy Combined With Apatinib Mesylate in the Treatment of Rhabdomyosarcoma in ChildrenChildhood RhabdomyosarcomaNCT03868852Xinhua Hospital, Shanghai Jiao Tong University School of Medicine48
招募中
2 期
Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCCEsophageal Squamous Cell Carcinoma (ESCC)ImmunotherapyNCT06603402Sichuan University41
招募中
2 期
Radiotherapy Combined With PD-1 Inhibitor and GM-CSF for Advanced Recurrent Metastatic Head and Neck TumorsObjective Response RateNCT05760196Xiangpan Li56