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Maintenance Immunotherapy With Deferred Salvage Radiotherapy After Response to Chemoimmunotherapy in Recurrent Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Summary
Re-irradiation is the most common clinical treatment for recurrent nasopharyngeal carcinoma; however, it is associated with severe complications which seriously affect patients' quality of life. Exploring deferred salvage radiotherapy until nasopharyngeal or cervical progression after PD 1 plus GP chemotherapy and immunotherapy maintenance is of great significance for improving the long-term survival and quality of life of patients with unresectable locally recurrent NPC. Thus, the investigators plan to conduct a multicenter, prospective, single-arm phase II clinical trial to evaluate the efficacy and safety of maintenance Immunotherapy with deferred salvage radiotherapy with an objective response to chemoimmunotherapy in patients with unresectable locally recurrent NPC .
Official title: Maintenance Immunotherapy With Deferred Salvage Radiotherapy in Patients With an Objective Response to Chemoimmunotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma: A Multicenter Phase 2 Single-Arm Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2026-07-22
Completion Date
2034-07-22
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
Maintenance Immunotherapy With Deferred Salvage Radiotherapy
1. Gemcitabine + Cisplatin Chemotherapy: Gemcitabine 1000 mg/m² on days 1 and 8 + Cisplatin 80 mg/m² on day 1, every 3 weeks, for 4-6 cycles. PD-1 Monoclonal Antibody Immunotherapy: Toripalimab 240 mg on day 1, every 3 weeks, or Tislelizumab 200 mg on day 1, every 3 weeks, or Camrelizumab 200 mg on day 1, every 3 weeks, for 4-6 cycles. 2. PD-1 Maintenance Therapy: Toripalimab 240 mg on day 1, every 3 weeks, or Tislelizumab 200 mg on day 1, every 3 weeks, or Camrelizumab 200 mg on day 1, every 3 weeks, until disease progression (according to RECIST v1.1; If progression is confined to the nasopharynx and/or neck without new metastatic lesions, salvage radiotherapy to these regions will be given, followed by continued immunotherapy maintenance until further progression), unacceptable toxicity, withdrawal of patient consent, or completion of a cumulative 2 years of treatment.
Locations (4)
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China