NCT05777824RecruitingPhase 2
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 · Last updated 11 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 7 Mar 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Head and neck cancer
- NCT number
- NCT05777824
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 84
- From 1 Jan 2023 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;
- Previously experienced head and neck radiation therapy;
- 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;
- 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;
Other illness
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
Who the study is looking for
- The subjects are not limited by gender, age from 18 to 75 years old;
- Histopathologically confirmed squamous cell carcinoma of the head and neck cancer;
- Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging;
- ECOG score 0-1;
- without distant metastasis;
- received induction chemotherapy plus immunotherapy, followed by surgery
- The expected survival is expected to be no less than 6 months.
- No contraindications to chemotherapy, immunotherapy, and radiotherapy;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC Coordinator of this site? Confirm its status | Beijin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.