Neoplasms

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Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

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Antibodies

Antibodies, Monoclonal

Cetuximab

Immunomodulating Agents

Immunoglobulins

Antineoplastic Agents, Immunological

Step 1：neoadjuvant anti-PD-1 antibody and TP chemotherapy every 3 weeks 2 cycles

Step 2： SBRT with GTV expanded 3mm , 24Gy/3F, every other day within one week after the immunochemotherapy

Step 3：Subsequent surgery and adjuvant treatments.

Radical surgery will be performed within 4-6 weeks after the second cycle of immunochemotherapy，no matter the situation of the tumor regresses.

Patients with pathological MPR/CR were treated with PD-1 antibody every two weeks up to 6 cycles after surgery with no adjuvant chemoradiotherapy. Those not achieved MPR/CR will receive adjuvant radiotherapy or chemoradiotherapy according to NCCN guidelines.

Step 1：neoadjuvant anti-PD-1 antibody and TP chemotherapy every 3 weeks 2 cycles

Step 2：Subsequent surgery and adjuvant treatments.

Radical surgery will be performed within 4-6 weeks after the second cycle of immunochemotherapy，no matter the situation of the tumor regresses.

Patients with pathological MPR/CR were treated with PD-1 antibody every two weeks up to 6 cycles after surgery without adjuvant chemoradiotherapy. Those not achieved MPR/CR will receive adjuvant radiotherapy or chemoradiotherapy according to NCCN guidelines.

Step 1：neoadjuvant anti-PD-1 antibody and TP chemotherapy combined with cetuximab every 3 weeks for 2 cycles

step2: Subsequent surgery and adjuvant treatments.

Radical surgery will be performed within 4-6 weeks after the second cycle of immunochemotherapy，no matter the situation of the tumor regresses.

Patients with pathological MPR/CR were treated with PD-1 antibody and cetuximab every two weeks up to 6 cycles after surgery without adjuvant chemoradiotherapy. Those not achieved MPR/CR will receive adjuvant radiotherapy or chemoradiotherapy according to NCCN guidelines.

SBRT radiotherapy，followed with PD-1 monoclonal antibody and TP chemotherapy

SBRT+immunochemotherpy

PD-1 monoclonal antibody and TP chemotheapy

Immunochemotherapy

PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab

cetuximab+immunochemotharpy

Feng Jiang, MD

feng Jiang, MD

The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC.

locally advanced HNSCC patients would receive PD-1 antibody and chemotherapy with or without SBRT covering GTV of primary disease and metastatic nodes , followed by surgery. pathological response was measured .Neoadjuvant PD-1 antibody and chemotherapy with certuxmab was also tested

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant SBRT in Localized Advanced HNSCC	NCT06306846	Head and Neck S...	SBRT+immunochem... Immunochemother... cetuximab+immun...	18 Years - 70 Years	Zhejiang Cancer Hospital
Neoadjuvant SBRT in Localized Advanced HNSCC	NCT06306846	Head and Neck S...	SBRT+immunochem... Immunochemother... cetuximab+immun...	18 Years - 70 Years	Zhejiang Cancer Hospital
Neoadjuvant SBRT in Localized Advanced HNSCC	NCT06306846	Head and Neck S...	SBRT+immunochem... Immunochemother... cetuximab+immun...	18 Years - 70 Years	Zhejiang Cancer Hospital

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