Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy

Head and Neck Cancer Clinical Trial

— HN  

Official title:

Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777824
• Other study ID #: 22/523-3725
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2023
• Est. completion date: December 30, 2027

Study information

• Verified date: February 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Yi Xu
• Phone: 15811166516
• Email: 694818945[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To develop postoperative stratification treatment for patients who have received induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk stratification is based on clinical characteristics and pathological responses. In order to achieve no inferior survival rate and a lower treatment-related toxicity rate than the standard treatment.

Description:

Induction chemotherapy combined with immunotherapy has shown promising efficacy in the treatment of patients with locally advanced head and neck cancers. However, how to choose a proper postoperative treatment remains unknown. Eligibility patients were assigned to two arms, each divided into three groups: observation, immunotherapy maintenance, and radiotherapy (50 Gy dose) plus immunotherapy maintenance group for low-risk arm; radiotherapy (50 Gy or 60Gy dose) plus immunotherapy maintenance groups, concurrent chemotherapy plus immunotherapy maintenance group for a high-risk arm. Disease-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. The subjects are not limited by gender, age from 18 to 75 years old;

2. Histopathologically confirmed squamous cell carcinoma of the head and neck cancer;

3. Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging;

4. ECOG score 0-1;

5. without distant metastasis;

6. received induction chemotherapy plus immunotherapy, followed by surgery

7. The expected survival is expected to be no less than 6 months.

8. No contraindications to chemotherapy, immunotherapy, and radiotherapy;

Exclusion Criteria:

1. Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)

2. Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;

3. Previously experienced head and neck radiation therapy;

4. Subjects who have used corticosteroids (>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone =10 mg/day are permitted;

5. Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity effusion drainage for the purpose of treatment within 2 weeks before enrollment;

6. Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Combination Product:
• anti-PD-1 or PD-L1 antibody
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy

Radiation:
• postoperative radiaotherapy
postoperative radiotherapy (60Gy or 50Gy)

Locations

Country	Name	City	State
China	National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC	Beijin	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment.	2 years
Secondary	Overall survival	defined as the time from random assignment to death from any cause or censored at the date of last follow-up.	2 years
Secondary	Local-Regional failure survival	defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment.	2 years
Secondary	Toxicity Adverse events	Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) and late radiation toxicities were assessed by NCI-CTCAE v5.0.	2 years