OncoMatch/Clinical Trials/NCT06345287
Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC
Is NCT06345287 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies anti-PD-1 or PD-L1 antibody for head and neck cancer.
Treatment: anti-PD-1 or PD-L1 antibody — The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV negative
HPV or P16 (-)
Required: CDKN2A P16 negative
HPV or P16 (-)
Disease stage
Required: Stage T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition)
Clinical staging is T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition); ... surgery is not recommended to preserve organ function, or the patient refuses surgery
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: chemotherapy — induction
undergo 2-4 cycles of induction chemotherapy
Must have received: immunotherapy — induction
undergo 2-4 cycles of induction ... immunotherapy
Cannot have received: anti-PD-1 therapy
Previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1
Cannot have received: immunotherapy targeting PD-1/PD-L1
Previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1
Lab requirements
Blood counts
WBC ≥ 3.0 × 10^9/L, ANC ≥ 2.0 × 10^9/L, PLT ≥ 100 × 10^9/L, HGB ≥ 90g/L (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulating factors correction)
Kidney function
BUN and CRE ≤ 1.5 × ULN, or endogenous creatinine clearance rate ≥ 60ml/min (Cockcroft Gout formula)
Liver function
TBIL ≤ 2.0 × ULN, ALT, AST ≤ 2.5 × ULN
Cardiac function
Good coagulation function: INR or PT ≤ 1.5 × ULN; myocardial enzyme spectrum is within the normal range
The functional level of the main organs meets the following standards: ... blood routine examination ... biochemical examination ... coagulation function ... myocardial enzyme spectrum
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06345287 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy, immunotherapy targeting PD-1/PD-L1 disqualifies patients from enrollment.
Does this trial require HPV?
Yes, HPV negative is a required biomarker for enrollment.
Does this trial require CDKN2A?
Yes, CDKN2A P16 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage T1-2N2-3M0 or T3-4N0-3M0 is required.
Is there an age limit?
Yes. Patients must be 75 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