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RECRUITING
NCT07528183
PHASE2

Maintenance Immunotherapy With Deferred Salvage Radiotherapy After Response to Chemoimmunotherapy in Recurrent Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

DRUG

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