Low-dose Radiotherapy (LDRT) Combined With Toripalimab and GP Chemotherapy for Recurrent/Metastatic Nasopharyngeal Carcinoma (LIGHT): A Single-Center, Open-Label, Single-Arm Phase II Clinical Study
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.
• 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.
• Patients with newly diagnosed metastatic NPC, or patients with locoregionally advanced NPC who developed metastasis ≥6 months or recurrence ≥12 months after completing radical radiotherapy/chemotherapy for the primary lesion.
• No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent/metastatic lesions.
• Adequate organ function, meeting the following criteria within 7 days prior to treatment:
‣ Hematological criteria (without transfusion or hematopoietic growth factor support within 14 days):
• Hemoglobin (Hb) ≥90 g/L.
∙ White Blood Cell (WBC) count ≥4.0 × 10⁹/L.
∙ Platelet count (PLT) ≥100 × 10⁹/L.
⁃ Biochemical criteria:
• Total Bilirubin (TBIL) ≤1.5 × Upper Limit of Normal (ULN).
∙ Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5 × ULN.
∙ Serum Creatinine (Cr) ≤1.5 × ULN AND Creatinine Clearance (CCr) ≥60 mL/min.
⁃ Coagulation function: INR and APTT ≤1.5 × ULN.
⁃ Normal results for myocardial injury markers, heart failure markers, and electrocardiogram (ECG). For patients with abnormal results in any of these, the investigator will assess the need for Doppler echocardiography.
⁃ Thyroid function: TSH ≤ ULN. If abnormal, FT3 and FT4 levels should be considered; patients can be enrolled if FT3 and FT4 levels are normal.
• Women of childbearing potential must have used reliable contraception, have a negative serum pregnancy test within 7 days before enrollment, and be willing to use adequate contraception during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterile. Men must agree to use adequate contraception or be surgically sterile during the trial and for 8 weeks after the last dose.
• Voluntary provision of signed informed consent, with good compliance.