Clinical trial · Interventional
Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy
Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-PD-1 or PD-L1 antibody | Combination Product | — | UNRESOLVED |
| postoperative radiaotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- NO_INTERVENTION
- label
- low-risk and PCR
- description
- Observation
- type
- EXPERIMENTAL
- label
- low-risk and MPR
- description
- immunotherapy maintenance
- interventionNames
- Combination Product: anti-PD-1 or PD-L1 antibody
- type
- EXPERIMENTAL
- label
- low-risk and IPR
- description
- postoperative radiotherapy (50 Gy) and immunotherapy maintenance
- interventionNames
- Combination Product: anti-PD-1 or PD-L1 antibody
- Radiation: postoperative radiaotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available