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PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Salvage Locoregional Radiotherapy in De Novo Metastatic NPC

ConditionsNasopharangeal CancerDistant Metastasis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Immediate locoregional radiotherapy

    Radiation

    Immediate locoregional radiotherapy (LRRT) with concurrent chemotherapy + PD-1 inhibitor Maintenance. Concurrent chemotherapy: Cisplatin (DDP) 80mg/m², starting on day 1 of radiotherapy, administered every 3 weeks during radiotherapy for a total of 3 cycles. PD-1 inhibitor maintenance therapy: Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years.

  • Salvage locoregional radiotherapy

    Radiation

    PD-1 inhibitor maintenance + Salvage locoregional radiotherapy PD-1 inhibitor maintenance therapy:Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1; if progression occurs in the nasopharynx or neck while metastatic lesions remain controlled, salvage locoregional radiotherapy\* will be administered and PD-1 maintenance will continue until subsequent progression), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years. \*Concurrent chemotherapy: Cisplatin (DDP) 80 mg/m², starting on day 1 of radiotherapy, administered every 3 weeks during radiotherapy for a total of 3 cycles.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Immediate locoregional radiotherapy groupActive comparator 1 intervention
Group B: Salvage locoregional radiotherapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Defined as the time from random assignment to death from any cause.

Time frame
2 year

Secondary outcomes

1

Locoregional progression-free survival

Defined as the time from random assignment to the occurrence of a locoregional progression.

Time frame
2 year
2

Distant progression-free survival

Defined as the time from random assignment to the occurrence of a distant progression.

Time frame
2 year
3

Progression free-survival

Defined as the time from random assignment to locoregional or distant progression, or death from any cause.

Time frame
2 year
4

Incidence of Acute and Late Toxicity

Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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