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Recruiting NCT05777824

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

Phase II Interventional Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: anti-PD-1 or PD-L1 antibody, postoperative radiaotherapy.
Who it may be relevant to
Registry conditions: Head and Neck Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Disease-free survival [Time frame: 2 years]
Secondary outcome measures (3)
  • Overall survival [Time frame: 2 years]
  • Local-Regional failure survival [Time frame: 2 years]
  • Toxicity Adverse events [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • The subjects are not limited by gender, age from 18 to 75 years old;
  • Histopathologically confirmed squamous cell carcinoma of the head and neck cancer;
  • Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging;
  • ECOG score 0-1;
  • without distant metastasis;
  • received induction chemotherapy plus immunotherapy, followed by surgery
  • The expected survival is expected to be no less than 6 months.
  • No contraindications to chemotherapy, immunotherapy, and radiotherapy;

Exclusion criteria

  • Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
  • Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;
  • Previously experienced head and neck radiation therapy;
  • 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;
  • 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;
  • Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS — Beijin

Identifiers

NCT: NCT05777824 · 22/523-3725

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗