SBRT Combined With PD-1 Antibody and Chemotherapy in Oligometastatic Nasopharyngeal Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT05524168
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SBRT — RADIATION
    SBRT for metastatic lesions
  • Camrelizumab — DRUG
    Maximum 6 cycles for combined therapy. Camrelizumab maintenance for 1 year.
  • Gemcitabine — DRUG
    Maximum 6 cycles for combined therapy.
  • Cisplatin — DRUG
    Maximum 6 cycles for combined therapy.

Study Details

This is a multicenter, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT combined with programmed death 1 (PD-1) antibody and chemotherapy in nasopharyngeal carcinoma patients with oligometastasis.

Key Dates

Start date
Nov 25, 2022
Status verified
May 2026
Primary completion
Jun 6, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SBRT+PD-1+Chemotherapy
    Patients will receive SBRT first, then PD-1 antibody (Camrelizumab 200mg/Q3W) and chemotherapy (cisplatin 80mg/m2 on d1, gemcitabine 1000mg/m2, d1 and d8, Q3W, maximum 6 cycles), followed by Camrelizumab (200mg/Q3W) until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 1 year treatment.

Primary Outcome Measure

Progression-free survival [ Time Frame: up to 12 months ]

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