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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.
Induction chemotherapy combined with immunotherapy has shown promising efficacy in the treatment of patients with locally advanced head and neck cancers. However, how to choose a proper postoperative treatment remains unknown. Eligibility patients were assigned to two arms, each divided into three groups: observation, immunotherapy maintenance, and radiotherapy (50 Gy dose) plus immunotherapy maintenance group for low-risk arm; radiotherapy (50 Gy or 60Gy dose) plus immunotherapy maintenance groups, concurrent chemotherapy plus immunotherapy maintenance group for a high-risk arm. Disease-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-risk and PCR | No Intervention | Observation | |
| low-risk and MPR | Experimental | immunotherapy maintenance |
|
| low-risk and IPR | Experimental | postoperative radiotherapy (50 Gy) and immunotherapy maintenance |
|
| high-risk and PCR | Experimental | postoperative radiotherapy (50 Gy) and immunotherapy maintenance |
|
| high-risk and MPR | Experimental | postoperative radiotherapy (60 Gy) and immunotherapy maintenance |
|
| high-risk and IPR | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-PD-1 or PD-L1 antibody | Combination Product | immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | defined as the time from random assignment to death from any cause or censored at the date of last follow-up. | 2 years |
| Local-Regional failure survival | defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Xu | Contact | 15811166516 | 694818945@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Junlin Yi, Doctor | National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC | Recruiting | Beijin | Beijing Municipality | 51000 | China |
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postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance
|
| postoperative radiaotherapy | Radiation | postoperative radiotherapy (60Gy or 50Gy) |
|
| 2 years |
| Toxicity Adverse events | Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) and late radiation toxicities were assessed by NCI-CTCAE v5.0. | 2 years |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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