An observational study in Non-Small Cell Lung Cancer, sponsored by Sun Yat-sen University. Status unknown at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Sun Yat-sen University · Observational
We hypothesized that TGR could serve as an early predictor of outcomes for aNSCLC patients undergoing immune checkpoint inhibitors (ICIs). A retrospective analysis was conducted to investigate the association of TGR with response and long-term survival of aNSCLC patients undergoing ICI therapy.
Tumor growth rate (TGR) signifies percentage change in tumor size per month (%/m). Electronic medical records were retrospectively reviewed for all histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.
All response and outcome evaluation were determined as per RECIST 1.1 by two senior radiologists blinded to patients'information. Discrepancy was solved by consensus.
X-tile software was used to determine cut-off values that maximumly differentiate overall survival (OS). Log-rank tests and Cox regression models were performed for survival analysis. The predictive value of TGR for clinical outcomes in ICI-treated aNSCLC patients was validated in two external cohorts, recruited form Guangdong Province Traditional Chinese Medical Hospital and Shanghai Chest Hospital.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 350 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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All histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy (N = 172) at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.
Exclusion Criteria:
Patients with low level of TGR determined by X-tile program
Other: This item is not applicable to our observational study.
Patients with high level of TGR determined by X-tile program
Other: This item is not applicable to our observational study.
This item is not applicable to our observational study.
Overall survival of patients undergoing ICI monotherapy
Overall survival (OS) was defined as the time from immunotherapy initiation to death from any causes.
Time frame: From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.
Progression-free survival of patients undergoing ICI monotherapy.
Progression-free survival was calculated from ICI initiation to radiologically-defined progression or death from any causes.
Time frame: From date of ICI treatment initiation until the date of first documented progression or date of death from any causes, whichever came first, assessed up to 100 months.
Plan to share: Yes — Data including demographic characteristics, clinical information, radiological and follow-up information will be shared.
Supporting information: Study protocol, Csr
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University