A Phase 2 interventional study of Toripalimab and Intensity modulated radiotherapy in Nasopharyngeal Carcinoma, T2-3N0 or T1-2N1 and EBV-DNA≤4000 Copy/ml, sponsored by XIANG YANQUN. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by XIANG YANQUN · Phase 2, Interventional, and Treatment
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).The primary end point is safety, the secondary end points are short-term efficacy,overall survival (OS), progression-free survival (PFS),Distant metastasis-free survival(DMFS),adverse effects ,quality of life and immune status assessment.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 45 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →XIANG YANQUN is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total
Drug: Toripalimab · Procedure: Intensity modulated radiotherapy
PD-1 Immune Checkpoint Inhibitor Combined With IMRT,used at 2 weeks before radiotherapy, once every 2 weeks, 10 cycles in total
Also known as: Programmed cell death protein 1(PD-1)；Immune checkpoint inhibitors（ICIs)
Intensity modulated radiotherapy
Adverse events
The severity of adverse events will be determined by the investigator based on CTCAE v 5.0
Time frame: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
overall survival (OS)
Patients in clinical trials were randomized to the time of death from any cause
Time frame: 2 years
progression-free survival (PFS)
The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause
Time frame: 2 years
Distant metastasis-free survival(DMFS)
Patients in clinical trials were randomized to the time of distant metastasis
Time frame: 2 years
Response rate (based on RECIST ver1.1)
According to the remission assessment criteria of solid tumors，divided into CR, PR, SD, PD. CR(complete response) All target lesions disappeared and no new lesions appeared PR ( partial response) reduction of the sum of the largest diameters of target lesions by ≥30%) SD(stable disease)the sum of the largest diameters of target lesions does not shrink to PR, or increases to PD PD(progressive disease) The sum of the largest diameters of target lesions increases by at least 20%, or new lesions appear
Time frame: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
Plan to share: Yes
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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