LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University
About this trial
This study aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial.
Eligibility criteria
Qualifiers
Age: 18-65 years old.
Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II or III).
ECOG Performance Status score of 0-1.
At least one measurable lesion as per RECIST v1.1 criteria.
Disqualifiers
Disease progression within 6 months after completing standard treatment for locoregionally advanced nasopharyngeal carcinoma.
Absence of identifiable tumor lesions in both the primary site and locoregional lymph nodes, precluding the development of an LDRT plan.
Inability to undergo MRI due to reasons such as implanted metal devices or claustrophobia.
Requirement for systemic use of corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose or during the study. Inhaled or topical steroids and adrenal replacement steroid doses >10 mg/day prednisone equivalent are permitted in the absence of active autoimmune disease. Physiological replacement doses of corticosteroids (≤10 mg/day prednisone equivalent) are allowed.
Trial design
Treatments tested in this trial
- Gemcitabine(GEM)
- Cisplatin
- Toripalimab
- LDRT
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov