计划状态
招聘阶段
第二阶段允许先接受免疫治疗
没有CRC 指导的试验
是药物
Sintilimab标签
MSS/ MMRp地点 | 位置状态 |
---|---|
中国 | |
复旦大学上海肿瘤防治中心 上海,上海 200032 |
招聘 |
联系方式
纳入标准
纳入标准
Aged 18-70 years old, regardless of gender
完全知情并愿意为试验提供书面知情同意书
ECOG 表 现 状 况 0-1
研究人员确定其预期寿命至少为 6 个月
Histologically confirmed colorectal adenocarcinoma, with MSS or pMMR status
Has 2-5 measurable metastatic lesions detected on imaging, with none of them indicated for surgery; or the participant refuses to receive surgery. Biopsy of metastasis is preferred, but not required
Has undergone at least one dose of first-line systemic chemotherapy, except for any type of immunotherapy
Multiple sites of lesions can be safely treated by SABR, and at least one lesion spared from irradiation, so as for assessment. The maximum diameter of each lesion for irradiation is no more than 5cm.
Demonstrate adequate organ function
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
排除标准
排除标准:
孕妇或哺乳期妇女
Serious medical comorbidities precluding radiotherapy
Prior radiotherapy to a site requiring treatment
Malignant pleural effusion
Inability to treat all sites of active disease
Has clinical or radiologic evidence of spinal cord compression or tumor within 3mm of spinal cord on MRI.
Dominant brain metastasis requiring surgical decompression
Has prior treatment with cancer immunotherapy including, but not limited to immune checkpoint inhibitors.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a dose of >10 mg Prednisone daily or equivalent at time of trial treatment.
Has a known history of active Bacillus Tuberculosis
Has active autoimmune disease that has required systemic treatment in the past 2 years
Hypersensitivity to PD-1 inhibitor or any of its excipients.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered from adverse events due to a previously administered agent.