Postoperative treatment for head and neck cancer based on response to chemotherapy and immunotherapy
Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy
This study is testing different follow-up treatments for patients with advanced head and neck cancer after they have received chemotherapy and immunotherapy to see which approach helps them stay cancer-free and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 1 site (Beijin, Beijing Municipality) |
| Trial ID | NCT05777824 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histopathologically confirmed locally advanced squamous cell carcinoma of the head and neck who have received induction chemotherapy and immunotherapy followed by surgery.
Not a fit: Patients with a history of past malignancies (except certain skin cancers), those who have received prior systemic anti-tumor therapy, or those with contraindications to chemotherapy, immunotherapy, or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective postoperative treatments for patients with head and neck cancer, potentially improving survival rates and reducing treatment-related side effects.
How similar studies have performed: While the combination of induction chemotherapy and immunotherapy has shown promise, this specific stratification approach in postoperative management is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijin, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.