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OncoMatch/Clinical Trials/NCT04992559

A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC

Is NCT04992559 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Consolidation Toripalimab for head and neck squamous cell carcinomas.

Phase 2RecruitingSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNCT04992559Data as of May 2026

Treatment: Consolidation ToripalimabThis study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage III

locally advanced head and neck squamous cell carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: radiation therapy — postoperative adjuvant

Have received postoperative adjuvant radiotherapy (chemo) therapy, and the end of the treatment is not more than 2 months.

Cannot have received: anti-PD-1 therapy

Has received prior therapy with an anti-PD-1 antibody

Cannot have received: investigational agent

Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment

Lab requirements

Blood counts

Absolute Neutrophil Count >1,500/µL; Platelets > 100 X 10^3/µL; Hemoglobin > 9.0 g/dL

Kidney function

Serum creatinine < 1.5 X ULN or CrCl > 40mL/min

Liver function

AST/ALT ≤ 3 x ULN; Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)

Adequate hepatic and renal function as demonstrated by... Adequate bone marrow function as demonstrated by...

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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