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

Phase 2

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Combination Product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy

• Registration Number: NCT05777824
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-02
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-18
• Study First Posted: 2023-03-21
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11
• Primary Completion: 2025-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-risk and IPR	anti-PD-1 or PD-L1 antibody	postoperative radiotherapy (50 Gy) and immunotherapy maintenance
low-risk and IPR	postoperative radiaotherapy	postoperative radiotherapy (50 Gy) and immunotherapy maintenance
high-risk and MPR	anti-PD-1 or PD-L1 antibody	postoperative radiotherapy (60 Gy) and immunotherapy maintenance
low-risk and MPR	anti-PD-1 or PD-L1 antibody	immunotherapy maintenance
high-risk and PCR	anti-PD-1 or PD-L1 antibody	postoperative radiotherapy (50 Gy) and immunotherapy maintenance
high-risk and IPR	postoperative radiaotherapy	postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance
high-risk and PCR	postoperative radiaotherapy	postoperative radiotherapy (50 Gy) and immunotherapy maintenance
high-risk and MPR	postoperative radiaotherapy	postoperative radiotherapy (60 Gy) and immunotherapy maintenance
high-risk and IPR	anti-PD-1 or PD-L1 antibody	postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance

Primary Outcome Measures

Name	Time	Method
Disease-free survival	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years	defined as the time from random assignment to death from any cause or censored at the date of last follow-up.
Local-Regional failure survival	2 years	defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment.
Toxicity Adverse events	2 years	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.

Trial Locations

Locations (1)

National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC; 🇨🇳 Beijin, Beijing, China