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Recruiting Phase 2 NCT06788002

LDRT and Chemoimmunotherapy in NPC With Liver Metastasis

Trial Parameters

Condition Nasopharyngeal Cancinoma (NPC)
Sponsor Hunan Cancer Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 26
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-01-14
Completion 2026-06-30
Interventions
Low-dose radiotherapy combine with chemoimmunotherapy

Brief Summary

This study aims to evaluate the efficacy and toxicity of adding low-dose radiotherapy to chemoimmunotherapy as a first-line treatment for nasopharyngeal carcinoma patients with liver metastasis.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years and ≤ 70 years, male or non-pregnant female. 2. Histologically confirmed with nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III) 3. Stage IVB (AJCC 8th edition staging) 4. De novo nasopharyngeal carcinoma with liver metastasis, or patients who had received curative treatment (radical radiotherapy or radical radiotherapy combined with chemotherapy) and developed liver metastasis more than 6 months after treatment completion. 5. ECOG performance status: 0 or 1 6. Must have at least one measurable lesion (assessed according to RECIST v1.1) 7. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; platelets ≥ 100 × 10\^9/L; hemoglobin ≥ 90 g/L. 8. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN 9. Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min. 10. Serum total b

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