Tislelizumab and radiation therapy in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type: a phase II study protocol.
Jia-Ying LiShu-Nan QiChen HuXin LiuYong YangTao WuRong ZhengXiao-Li FengXiao-Guang NiFeng-Yan JinYu-Qin SongWei-Ping LiuSheng-Yu ZhouYe-Xiong LiPublished in: Future oncology (London, England) (2023)
Low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type has a favorable outcome with radiation therapy alone, and the addition of chemotherapy shows no survival benefit. Nonetheless, a proportion of patients will relapse or progress, with a dismal outcome, highlighting the need for a novel therapeutic strategy. Promising preliminary findings indicate the efficacy of PD-1/PD-L1 inhibitors in extranodal natural killer/T-cell lymphoma, nasal type, with good toxicity profiles. Here we describe the design of a phase II study (CLCG-NKT-2101), which is evaluating the safety and efficacy of adding anti-PD-1 antibody to the current radiation therapy regimen in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type patients. Tislelizumab will be added in an inductive and concurrent way to radiation therapy. The primary end point will be the complete response rate after induction immunotherapy. Clinical trial registration: ClinicalTrials.gov (NCT05149170).
Keyphrases
- radiation therapy
- early stage
- clinical trial
- locally advanced
- phase ii
- end stage renal disease
- phase ii study
- open label
- ejection fraction
- study protocol
- newly diagnosed
- chronic kidney disease
- randomized controlled trial
- prognostic factors
- peritoneal dialysis
- squamous cell carcinoma
- rectal cancer
- oxidative stress
- neoadjuvant chemotherapy
- placebo controlled
- double blind
- sentinel lymph node
- free survival