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Updated: Jan 15, 2026
Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment
Published on: April 22, 2019
TQB2450 plus intensity-modulated radiotherapy in recurrent nasopharyngeal carcinoma: An open-label, single-arm, phase
Tian-Liang Xia1, Wenxuan Huang2, You-Ping Liu3
1State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China.
Background:
TQB2450 is a promising humanized monoclonal antibody targeting programmed death ligand 1, but its potential role in the treatment of nasopharyngeal carcinoma (NPC) is unclear.
Methods:
In this single-arm phase II trial (ClinicalTrials.gov: NCT04895345), 25 patients with unresectable recurrent NPC (rNPC) received intensity-modulated radiotherapy (IMRT) alongside TQB2450, administered intravenously at a dose of 1,200 mg every 3 weeks, with a median treatment duration of 17 cycles. The primary endpoint was the objective response rate (ORR) 3 months after completion of radiotherapy, with key secondary endpoints including progression-free survival (PFS) and safety. Integrated genomic and spatial transcriptomic analyses were performed to characterize the patient population benefitting from this combination therapy.
Findings:
The ORR of this trial is 72.0% (95% confidence interval [CI]: 50.6-87.9). The median PFS is 29.60 months (95% CI: 15.11 to not reached). Treatment-related grade ≥3 adverse events are observed in 10 patients (40.0%), with the most common being nasopharyngeal necrosis (32.0%). Serial plasma circulating Epstein-Barr virus (EBV) DNA detection can predict PFS outcomes. Lower baseline T cell receptor (TCR) diversity in the blood is associated with improved PFS. Spatial transcriptomic analyses reveal that low immune infiltration and elevated expression of macrophage migration-inhibitory factor (MIF) in the tumor are linked to treatment resistance.
Conclusions:
This combination therapy shows promising efficacy with a manageable safety profile in rNPC patients. Determination of MIF levels, tumor microenvironment characteristics, TCR profiling, and serial EBV DNA monitoring could identify patients who derive benefits from this therapeutic approach.
Funding:
National Natural Science Foundation of China.
