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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | 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. |
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| control | Active Comparator | 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. |
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| Cetuximab+immunochemo | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT+immunochemotherpy | Radiation | SBRT radiotherapy,followed with PD-1 monoclonal antibody and TP chemotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| major pathology response (MPR) | major pathology response | 4-6 weeks after the end of the neoadjuvant therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Jiang, MD | Contact | 0086-571-88128202 | jiangfeng@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| feng Jiang, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| Immunochemotherapy | Drug | PD-1 monoclonal antibody and TP chemotheapy |
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| cetuximab+immunochemotharpy | Drug | PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab |
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