This is a phase II clinical trial of SHR-1210 (an anti-PD-1 Inhibitor) simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC. It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
RECRUITINGClinically significant toxicity
above grade 3 AEs
Time frame: First cycle (28 days)
6-month-PFS
6-month-progression free survival rate
Time frame: From the start of treatment to 6 months.
AEs+SAEs
Adverse Events and Serious Adverse Events
Time frame: from the first drug administration to within 30 days for the last SHR-1210 dose
PFS
Progression-Free-Survival
Time frame: up to 2 years
ORR
Objective Response Rate
Time frame: At baseline,at the time point of every 8 weeks
DCR
Disease Control Rate
Time frame: at the time point of every 8 weeks
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Time frame: up to 2 years
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