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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
High- and Low-dose radiotherapy combined with immunotherapy and maintain immunotherapy. Immunotherapy (Envafolimab) once every week (maintain a total of two years). Continuous high-(8Gy×5F) and low-dose (1.33Gy×5F) Radiotherapy starts at the second week after immunotherapy.
Xiaochang Gong
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGJiangxi Cancer Hospital
Nanchang, Jiangxi, China
RECRUITINGObjective response rate (ORR)
the proportion of patients achieving the optimal overall remission (complete or partial remission)
Time frame: 6 months
Progression-free survival (PFS)
the time from the start of treatment to the first observation of disease progression or death from any cause (whichever occurs first)
Time frame: two year
Overall survival (OS)
the time from the start of treatment to death from any cause
Time frame: two years
Safety evaluation
NCI-CTCAE version 5.0 to assess adverse events (therapeutic toxicity)
Time frame: two years
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