Neoadjuvant Stereotactic Body Radiotherapy（SBRT）Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Status: Recruiting

Location: See location...

Intervention Type: Drug, Radiation

Study Type: Interventional

Study Phase: Phase 2

SUMMARY

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 70

Healthy Volunteers: f

View:

• Pathologically confirmed initially resectable Localized advanced head and neck squamous cell carcinoma，and plan for surgical resection.

• Immunohistochemical confirmed the HPV status through P16 immunostaining.

• Male or female, Between the aged from 18 to 70 years,

• Able to provide informed consent, comply with agreements, and sign research specific consent documents.

• ZPS is less than 2.

• Adequate bone marrow, liver and kidney, heart , lung and other physiological function determined by Researchers, able to tolerate neoadjuvant anti-PD-1, anti-EGFR, and radiation therapy.

• Subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe.

Locations

Other Locations

China

Zhejiang Cancer Hospital

RECRUITING

Hangzhou

Contact Information

Primary

Feng Jiang, MD

jiangfeng@zjcc.org.cn

0086-571-88128202

Time Frame

Start Date: 2023-10-01

Estimated Completion Date: 2026-12-31

Participants

Target number of participants: 81

Treatments

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.

Active_comparator: control

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.

Active_comparator: Cetuximab+immunochemo

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.

Related Therapeutic Areas

Head and Neck Squamous Cell Carcinoma (HNSCC)

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Neoadjuvant Stereotactic Body Radiotherapy（SBRT）Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

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