NCT06323239 SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma
| NCT ID | NCT06323239 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2026-07-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Eligibility Criteria
Inclusion Criteria: * Diagnosed as recurrence/metastatic NPC * Histopathological diagnosis of NPC(WHO II/III) * ECOG 0-1 point * No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; * No contraindications to immunotherapy and chemoradiotherapy; * At least one lesion could receive SBRT safely; * Subject must have a measurable target lesion based on RECIST v1.1; * Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/ L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L; * Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN; * Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); * Take effective contraceptions during and three months after treatment; * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin; * Unexplained fe