A Phase 2 interventional study of SHR-1210 in Non-Small-Cell Lung Cancer, sponsored by Shandong Cancer Hospital and Institute. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Shandong Cancer Hospital and Institute · Phase 2, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 42 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shandong Cancer Hospital and Institute is the lead sponsor of 103 studies on the registry; 36 are open to participants now.
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SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
Drug: SHR-1210
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
Also known as: Hypofraction Radiotherapy
Clinically 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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Shandong Cancer Hospital and Institute