Neoadjuvant SBRT in Localized Advanced HNSCC

NCT06306846 | Recruiting Phase 2

• 1 other identifier: 11235794
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Carcinoma

Outcome Measures

Primary Outcomes (1)

• major pathology response (MPR)

  major pathology response

  4-6 weeks after the end of the neoadjuvant therapy

Study Arms (3)

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.

Radiation: SBRT+immunochemotherpy

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.

Drug: Immunochemotherapy

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.

Drug: cetuximab+immunochemotharpy

Interventions

SBRT+immunochemotherpy RADIATION

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

Also known as: immunochemotherapy

experimental

Immunochemotherapy DRUG

PD-1 monoclonal antibody and TP chemotheapy

control

cetuximab+immunochemotharpy DRUG

PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab

Cetuximab+immunochemo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any clinical illness, such as hemorrhage, active infection, or mental illness, that can hinder safe participation or adherence of research procedures.
• Patients who cannot accept radiotherapy in standard treatment.
• Long term maintenance of oral steroids (≥ 20mg prednisone equivalent per day) is required, excluding patients with inhaled, local, or non absorbable steroids.
• 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.

Sponsors & Collaborators

• Jiang Feng: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Study Officials

• feng Jiang, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Jiang, MD

CONTACT

0086-571-88128202; jiangfeng@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CN (1)