OncoMatch/Clinical Trials/NCT05980715
PD-1 Inhibitor Therapy Versus Radiotherapy in pCR Patients With Locally Advanced HNSCC After Neoadjuvant Immunochemotherapy
Is NCT05980715 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies PD-1inhibitor for hnscc.
Treatment: PD-1inhibitor — In patients with locally advanced head and neck squamous cell carcinoma undergoing standard surgical treatment after neoadjuvant immunochemotherapy, can PD-1 inhibitor therapy be used instead of adjuvant radiotherapy for both primary and lymph node pathology? To provide further evidence-based medical evidence for the late precision treatment of HNSCC patients after neoadjuvant immunochemotherapy. Avoid the side effects caused by excessive radiotherapy, especially avoid the occurrence of second primary cancer, radiation osteonecrosis and other diseases. 1. Main study endpoint: A randomized controlled, non-inferiority, multicentre Phase III trial was conducted to investigate the difference in 5-year overall survival (OS) between experimental group (Group B) and control group (group A) in patients undergoing standard surgical treatment after neoadjuvant immunochemotherapy for locally advanced HNSCC, with both primary and lymph node pathology revealed by pCR. At the same time, adverse events and safety were evaluated according to NCI-CTCAE 5.0 criteria and RTOG later radiotherapy damage evaluation criteria. Safety indicators focused on late radiotherapy toxicity and the incidence of grade 3 and 4 adverse reactions in NCI-CTC AE 5.0 and RTOG. The differences in the incidence of grade 3 and 4 adverse events were compared between the experimental group and the control group. 2. Secondary study endpoint: The differences in 2-year disease-free survival (DFS), regional relapse-free survival (RRFS), distant metastasis free survival (DMFS), safety and adverse events were compared. Safety evaluation NCI-CTC AE 5.0 standard was used to evaluate the acute safety index of radiotherapy, and RTOG late-stage damage evaluation standard was used to evaluate the late-stage safety index of radiotherapy. 4\) Exploratory goals The influence of prognostic laboratory indicators, clinical risk factors were analyzed. To explore the factors that influence the efficacy of radiotherapy after pCR immunotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage T3, N0, M0, T1-T3, N1-N2, M0, T4A, N0-2, M0 (AJCC 8th)
Locally advanced squamous cell carcinoma of head and neck includes: i) T3, N0, M0; 2) T1-T3, N1-N2, M0; 3) T4a, N0-2, M0.
Prior therapy
Must have received: neoadjuvant immunochemotherapy — neoadjuvant
underwent standard surgical treatment after neoadjuvant immunochemotherapy and showed pCR in both primary lesions and lymph node pathology
Must have received: surgery — post-neoadjuvant
underwent standard surgical treatment after neoadjuvant immunochemotherapy and showed pCR in both primary lesions and lymph node pathology
Lab requirements
Blood counts
ANC ≥1.5x10^9/L in the last 14 days without G-CSF; Platelets ≥100×10^9/L without blood transfusion in past 14 days; Hemoglobin ≥9g/dL without blood transfusion or erythropoietin within last 14 days
Kidney function
Serum creatinine ≤1.5×ULN and creatinine clearance ≥60 ml/min
Liver function
Total bilirubin ≤1.5× ULN; AST and ALT ≤2.5×ULN (≤5×ULN in patients with liver metastasis)
Cardiac function
Myocardial enzyme profile within normal range (unless abnormality not clinically significant); Good coagulation function (INR or PT ≤1.5×ULN)
Normal baseline inspection: ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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