NCT05777824 Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy
| NCT ID | NCT05777824 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 84 participants in total. It began in 2023-01-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Junlin Yi, Doctor
STUDY CHAIR
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Frequently Asked Questions
Who can join the NCT05777824 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05777824 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05777824 currently recruiting?
Yes, NCT05777824 is actively recruiting participants. Contact the research team at 694818945@qq.com for enrollment information.
Where is the NCT05777824 trial being conducted?
This trial is being conducted at Beijin, China.
Who is sponsoring the NCT05777824 clinical trial?
NCT05777824 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Junlin Yi, Doctor at National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC. The trial plans to enroll 84 participants.
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