OncoMatch/Clinical Trials/NCT05340491
Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
Is NCT05340491 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Toripalimab and Chemotherapy for nasopharyngeal carcinoma.
Treatment: Toripalimab · Chemotherapy — This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage RII, RIII, RIVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: radiotherapy
No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy
Cannot have received: chemotherapy
No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy
Cannot have received: immunotherapy
No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy
Cannot have received: biotherapy
No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy
Cannot have received: anti-tumor Chinese medicine treatment
Treated with anti-tumor Chinese medicine treatment
Cannot have received: PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway
Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway
Lab requirements
Blood counts
WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L
Kidney function
BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula)
Liver function
ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN
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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05340491 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage RII or RIII or RIVA is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages