Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy
NCT ID: NCT05777824
Last Updated: 2023-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2023-01-01
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low-risk and PCR
Observation
No interventions assigned to this group
low-risk and MPR
immunotherapy maintenance
anti-PD-1 or PD-L1 antibody
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
low-risk and IPR
postoperative radiotherapy (50 Gy) and immunotherapy maintenance
anti-PD-1 or PD-L1 antibody
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
postoperative radiaotherapy
postoperative radiotherapy (60Gy or 50Gy)
high-risk and PCR
postoperative radiotherapy (50 Gy) and immunotherapy maintenance
anti-PD-1 or PD-L1 antibody
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
postoperative radiaotherapy
postoperative radiotherapy (60Gy or 50Gy)
high-risk and MPR
postoperative radiotherapy (60 Gy) and immunotherapy maintenance
anti-PD-1 or PD-L1 antibody
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
postoperative radiaotherapy
postoperative radiotherapy (60Gy or 50Gy)
high-risk and IPR
postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance
anti-PD-1 or PD-L1 antibody
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
postoperative radiaotherapy
postoperative radiotherapy (60Gy or 50Gy)
Interventions
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anti-PD-1 or PD-L1 antibody
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
postoperative radiaotherapy
postoperative radiotherapy (60Gy or 50Gy)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Junlin Yi, Doctor
Role: STUDY_CHAIR
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Locations
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National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Beijin, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22/523-3725
Identifier Type: -
Identifier Source: org_study_id
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