{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["4(11)"],"submitter":["Chen SY"],"pubmed_abstract":["Locoregional radiotherapy added to chemotherapy has significantly improved survival in de novo metastatic nasopharyngeal carcinoma (mNPC). However, only 54% of de novo mNPC patients who received sequential chemoradiotherapy have complete or partial response 3 months after radiotherapy. This Simon's optimal two-stage design phase II study (NCT04398056) investigates whether PD-1 inhibitor could improve tumor control in combination with chemoradiation. The primary endpoint is objective response rate (ORR) at 3 months after radiotherapy. Twenty-two patients with primary mNPC are enrolled. The ORR at 3 months after radiotherapy is 81.8% (22.7% complete response, n = 5; 59.1% partial response, n = 13), and the disease control rate is 81.8%. The 3-year progression-free survival (PFS) rate is 44.9% (95% confidence interval 26.4%-76.3%). Fifteen patients (68.2%) experienced grade 3-4 adverse events. Patients with high baseline plasma Epstein-Barr virus DNA copy number (>10<sup>4</sup> cps/mL) show worse PFS. Addition of toripalimab to sequential chemoradiotherapy suggests promising tumor response in patients with primary mNPC."],"journal":["Cell reports. Medicine"],"pagination":["101279"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10694661"],"repository":["biostudies-literature"],"pubmed_title":["Efficacy of sequential chemoradiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma: A phase II trial."],"pmcid":["PMC10694661"],"pubmed_authors":["Xu GQ","Duan CY","Gu CM","Chen SY","Chen MY","Duan XT","Hua YJ","Jiang R","Zhang MX","You R","Xie RQ","Huang PY","Zou X","Liu YP","Ding X","Zhang WJ","Lin C","Wang ZQ","Ouyang YF","Yang Q","Peng L","Li HF","Lin M","Xie YL"],"additional_accession":[]},"is_claimable":false,"name":"Efficacy of sequential chemoradiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma: A phase II trial.","description":"Locoregional radiotherapy added to chemotherapy has significantly improved survival in de novo metastatic nasopharyngeal carcinoma (mNPC). However, only 54% of de novo mNPC patients who received sequential chemoradiotherapy have complete or partial response 3 months after radiotherapy. This Simon's optimal two-stage design phase II study (NCT04398056) investigates whether PD-1 inhibitor could improve tumor control in combination with chemoradiation. The primary endpoint is objective response rate (ORR) at 3 months after radiotherapy. Twenty-two patients with primary mNPC are enrolled. The ORR at 3 months after radiotherapy is 81.8% (22.7% complete response, n = 5; 59.1% partial response, n = 13), and the disease control rate is 81.8%. The 3-year progression-free survival (PFS) rate is 44.9% (95% confidence interval 26.4%-76.3%). Fifteen patients (68.2%) experienced grade 3-4 adverse events. Patients with high baseline plasma Epstein-Barr virus DNA copy number (>10<sup>4</sup> cps/mL) show worse PFS. Addition of toripalimab to sequential chemoradiotherapy suggests promising tumor response in patients with primary mNPC.","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Nov","modification":"2026-06-23T03:21:19.944Z","creation":"2025-04-19T17:02:43.323Z"},"accession":"S-EPMC10694661","cross_references":{"pubmed":["37951218"],"doi":["10.1016/j.xcrm.2023.101279"]}}