Main Session
Sep
29
PQA 07 - Head and Neck Cancer, Lung Cancer/Thoracic Malignancies, and Nursing and Supportive Care
3459 - Phase II Trial of QL1706 in Combination with Liposomal Irinotecan for Recurrent or Metastatic Nasopharyngeal Carcinoma Progressing after Anti-PD-(L)1 Therapy
Presenter(s)
Yesheng Du, RT - Department of Radiation Oncology, Chongqing University Cancer Hospital, Chongqing, Chong Qing
Y. Du, X. Zhang, C. Wang, and J. D. Sui; Radiation Oncology Center, Chongqing University Cancer Hospital, Chongqing, China
Purpose/Objective(s):
Programmed death-1 (PD-1) inhibitors in combination with gemcitabine and cisplatin chemotherapy constitute the standard first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (rmNPC). However, patients with disease progression after anti-PD-1 therapy have a dismal prognosis, and no standardized salvage regimen has been established to date. QL1706 is a bifunctional monoclonal antibody pair (MabPair) targeting both PD-1 and CTLA-4. The present study is designed to evaluate the safety and efficacy of QL1706 plus liposomal irinotecan in patients with rmNPC who progressed after anti-PD-(L)1 antibody therapy.Materials/Methods:
This is a single-center, single-arm, phase II clinical trial. Eligible patients are those with rmNPC who have experienced disease progression after at least one line of systemic therapy comprising platinum-based chemotherapy combined with anti-PD-(L)1 monoclonal antibody. Patients are required to have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) on radiographic assessment. A total of 36 patients are planned for enrollment. All enrolled patients will receive QL1706 at a dose of 5 mg/kg administered intravenously on day 1 of each 3-week cycle, in combination with liposomal irinotecan at 70 mg/m² intravenously on day 1 of each 3-week cycle. Treatment will be continued until disease progression, development of unacceptable toxicity, or patient withdrawal. The primary endpoint is the objective response rate (ORR). Secondary endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile. As of February 14, 2026, 2.8% of the planned 36 subjects have been enrolled. This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2500110090).Results:
Clinical trial in progress.Conclusion:
Clinical trial in progress.