Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05777824

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2023-10-11

84

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Histopathologically confirmed squamous cell carcinoma of the head and neck
  • Locally advanced cancer diagnosed as T3-4 or N+ stage according to AJCC 8th edition
  • ECOG performance score of 0 or 1
  • No distant metastasis present
  • Received induction chemotherapy plus immunotherapy followed by surgery
  • Expected survival of at least 6 months
  • No contraindications to chemotherapy, immunotherapy, and radiotherapy
Not Eligible

You will not qualify if you...

  • History of past malignancies except stage I non-melanoma skin cancer or cervical carcinoma in situ
  • Received systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy
  • Previous radiation therapy to the head and neck region
  • Use of corticosteroids over 10 mg/day prednisone or other immunosuppressive agents within 1 month before enrollment (except certain permitted uses)
  • Presence of pleural, pericardial effusion, or ascites requiring drainage or recent drainage within 2 weeks
  • Severe comorbid conditions including myocardial infarction, arrhythmia, cerebral vascular disease, ulcer disease, mental illness, or uncontrolled diabetes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC

Beijin, Beijing Municipality, China, 51000

Actively Recruiting

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Research Team

Y

Yi Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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