OncoMatch/Clinical Trials/NCT06241599
A Multi-center, Randomized, Double-blind, Phase II/III Clinical Trial of AK104 or Placebo in Combination With Chemotherapy as Second-line or More Lines for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Is NCT06241599 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies GP/PFLL+AK104 for recurrent or metastatic nasopharyngeal carcinoma.
Treatment: GP/PFLL+AK104 — To compare whether AK104 combined with GP or PFLL can improve survival benefit, safety and tolerability in nasopharyngeal carcinoma patients who have failed first-line treatment; To compare the survival benefits of GP or GFLL treatment in nasopharyngeal carcinoma patients who had failed first-line therapy; To compare the survival benefits of GP or GFLL combined with AK104 in patients with nasopharyngeal carcinoma who had failed first-line therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IV (UICC/AJCC 8th edition)
Metastatic disease required
For patients with recurrent and metastatic nasopharyngeal carcinoma who are not eligible for local treatment and meet the definition of the staging system (8th edition) of the International Union against Cancer and the American Joint Committee on Cancer (UICC/AJCC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: first-line treatment — recurrent or metastatic
Patients with nasopharyngeal carcinoma recurrence and metastasis who failed first-line treatment
Cannot have received: CTLA-4 and PD1-specific antibody therapy (simultaneous use)
In the past, CTLA-4 and PD1-specific antibody therapy were used simultaneously
Lab requirements
Blood counts
Neutrophil absolute count (ANC) ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥8.0g/dl (through blood transfusion or other intervention is acceptable)
Kidney function
Creatinine clearance ≥50mL/min (using the standard Cockcroft-Gault formula)
Liver function
Bilirubin ≤ 1.5x ULN, ALT and AST≤ 1.5x ULN; If there is liver metastasis, ALT and AST are less than 5 times ULN
Cardiac function
No heart failure of NYHA2 or above; no unstable angina; no myocardial infarction within 1 year; no clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
The functions of vital organs meet the following requirements... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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