The Combination of Immunotherapy and Stereotactic Ablative Radiotherapy in MSS Oligometastatic Colorectal Cancer

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

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

Zhen Zhang, MD, PhD
联系方式
18801735029 zhen_zhang@fudan.edu.cn

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.

NCT ID

NCT04535024

添加审判日期

2020-09-01

更新日期

2021-05-11