A Randomized Phase II Study of CONsolidation PEmbrolizumab After Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Patients will be treated with pembrolizumab after concurrent chemoradiotherapy with cisplatin. Patients will be treated with up to 17 cycles (approximately 1 year) of pembrolizumab until disease progression or recurrence
• Histologically or cytologically diagnosed nasopharyngeal carcinoma(NPC)
‣ WHO Type 2a, 2b nonkeratinizing, undifferentiated subtype
⁃ Keratinizing subtype is excluded due to less associated with EBV infection
• Stage II-IVB Locally advanced disease
• a. Stage II-IVB disease must confirmed by initial CT and/or MRI, PET CT at initial diagnosis according to the AJCC 8th edition
• Prior Therapy
‣ Patients must have received curative radiotherapy (radiation dose ≥ 60Gy) and concurrent cisplatin (cumulative dose ≥ 200mg/m2)
⁃ Induction chemotherapy followed by CCRT is permissible
⁃ CCRT followed by adjuvant FP is permissible
⁃ Patients must have recovered Gr2 or less than Gr2 from all acute, reversible toxic effects from chemotherapy and radiotherapy (excluding alopecia)
• Age 19 or more than 19 years old
• The patient must have an ECOG performance status of 0, 1
• Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
• patient with the willingness to comply with the study protocol during the study period and capable of complying with it
• A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.
• Have adequate organ function as defined in the following . Specimens must be collected within 10 days prior to the start of study treatment.
∙ Hematological Absolute neutrophil count (ANC) ≥1500/µL Platelets ≥100 000/µL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine ≤1.5 × ULN OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)