Postoperative treatment for head and neck cancer based on response to chemotherapy and immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop a postoperative treatment strategy for patients with locally advanced head and neck squamous cell carcinoma who have undergone induction chemotherapy and immunotherapy. Patients will be stratified based on their clinical characteristics and pathological responses into low-risk and high-risk groups. Each group will receive different postoperative treatments, including observation, immunotherapy maintenance, and varying doses of radiotherapy combined with immunotherapy. The study will evaluate disease-free survival, overall survival, and treatment-related toxicity to determine the efficacy of these approaches.

Why it matters

Who can join: the full rules

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

Where it's running

• National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
  Beijin, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yi Xu
• Email: 694818945@qq.com
• Phone: 15811166516

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Phenotype-based Pain Guidance for Head and Neck Cancer-Related Pain (pilot)

  This pilot test sees if tailoring pain treatment to a patient’s pain type can reduce head and neck cancer pain in adults who haven’t started cancer treatment yet.

  Recruiting Phase 2 Shaukat Khanum Memorial Cancer Hospital & Research Centre · Lahore, Punjab Province · NCT07919444

• Airway ultrasound in head and neck cancer patients

  This observational study tests whether neck ultrasound measurements of the airway match CT measurements in adults with maxillofacial cancer undergoing surgery with anesthesia.

  Recruiting at 2 sites University Hospital Dubrava · Zagreb, City of Zagreb and 1 other locations · NCT07910149

• Safe use of metformin and naproxen to help prevent cancer in people with Fanconi anemia

  This study tests whether metformin and naproxen can lower the chance of cancer developing in adults with Fanconi anemia.

  Recruiting at 2 sites Phase 1 Rockefeller University · Minneapolis, Minnesota and 1 other locations · NCT07901959

• Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer

  In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07882888

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

• Using Silverlon for head and neck patients with tracheostomies

  This early-phase study tests whether Silverlon dressings can prevent severe skin reactions under tracheostomy collars in adults with head and neck cancer.

  Recruiting Phase 1 State University of New York - Upstate Medical University · Syracuse, New York · NCT07856732

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.