PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Salvage Locoregional Radiotherapy in De Novo Metastatic NPC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
This phase III randomized trial evaluates PD-1 inhibitor plus chemotherapy followed by immediate versus salvage locoregional radiotherapy in de novo metastatic nasopharyngeal carcinoma. The study aims to evaluate whether salvage locoregional radiotherapy is non-inferior to immediate radiotherapy following PD-1 inhibitor plus GP in de novo metastatic NPC, with potential for reduced toxicity.
Eligibility criteria
Qualifiers
Age 18-70 years, any gender.
Histologically confirmed differentiated non-keratinizing carcinoma or undifferentiated non-keratinizing carcinoma by tissue biopsy, with radiologically detectable metastatic lesions. Pathological confirmation of metastatic lesions is recommended but not mandatory.
ECOG performance status 0-1.
Stage IV NPC according to the 9th edition of the UICC/AJCC staging system.
Disqualifiers
Prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.
Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors.
Presence of uncontrolled or symptomatic central nervous system (CNS) metastases.
History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.
Trial design
Treatments tested in this trial
- Immediate locoregional radiotherapy
- Salvage locoregional radiotherapy
Treatment groups
260 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Sponsor institution
Source ClinicalTrials.gov