Neoadjuvant SBRT in Localized Advanced HNSCC

NCT ID: NCT06306846

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

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

Conditions

Head and Neck Squamous Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SBRT+immunochemotherpy

Intervention Type: RADIATION

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

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.

Group Type: ACTIVE_COMPARATOR

Immunochemotherapy

Intervention Type: DRUG

PD-1 monoclonal antibody and TP chemotheapy

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.

Group Type: ACTIVE_COMPARATOR

cetuximab+immunochemotharpy

Intervention Type: DRUG

PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab

Interventions

SBRT+immunochemotherpy

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

Intervention Type: RADIATION

Immunochemotherapy

PD-1 monoclonal antibody and TP chemotheapy

Intervention Type: DRUG

cetuximab+immunochemotharpy

PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab

Intervention Type: DRUG

Other Intervention Names

immunochemotherapy

Eligibility Criteria

Inclusion Criteria

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

2. Immunohistochemical confirmed the HPV status through P16 immunostaining.

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

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

5. ZPS is less than 2.

6. 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.

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

Exclusion Criteria

1. Any clinical illness, such as hemorrhage, active infection, or mental illness, that can hinder safe participation or adherence of research procedures.

2. Patients who cannot accept radiotherapy in standard treatment.

3. Long term maintenance of oral steroids (≥ 20mg prednisone equivalent per day) is required, excluding patients with inhaled, local, or non absorbable steroids.

4. Autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathy (such as Guillain Barre syndrome), etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiang Feng

OTHER

Sponsor Role: lead

Responsible Party

Jiang Feng

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

feng Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Jiang, MD

Role: CONTACT

jiangfeng@zjcc.org.cn

0086-571-88128202

Facility Contacts

Feng Jiang, MD

Role: primary

jiangfeng@zjcc.org.cn

0086-571-88128202

Other Identifiers

11235794

Identifier Type: -

Identifier Source: org_study_id