A Phase 2 interventional study of PD-1 blocking antibody in Solid Tumor, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-28.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
This is a phase II study to observe efficacy of combining local radiotherapy with PD-1blockade in patients with advanced solid tumors. All patients will accept at least one site of radiotherapy together with PD-1 blockade. The study will evaluate changes of unirradiated and irradiated lesions.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 55 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Progression after ≥ 1 prior line of therapy regimen with no standard treatment regimen or intolerable toxicities, including all three of the following:
Exclusion Criteria:
Local irradiation + immunotherapy
Drug: PD-1 blocking antibody
All patients with more than one distant metastatic lesions will accept at least one site of radiotherapy and PD-1 blockade at the same time.
Also known as: irradiation
Objective response rate
The proportion of patients with a tumor volume reduction of 30% lasting for at least 4 weeks,and is the sum of the proportion of complete remission (CR) and partial remission (PR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed at least 4 weeks
non-irradiated lesion control rate(NRCR)
The percentage of non-irradiated target lesions with CR/PR or SD
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Progression free survival
The time from enrollment to disease progression or death from any cause
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Overall survival
The time from enrollment to death from any cause
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Rate of side effects
≥ grade 3 adverse effects
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Plan to share: No
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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital