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Patients with locally advanced (stage III to stage IVB) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) who meet the inclusion criteria will have their blood samples collected, tumor tissue samples or patient paraffin tissue, and slides for comprehensive genomic sequencing and analysis. The study is divided into two groups. Arm1 group: Patients with stage IVB (T4bNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 to 3 cycles (determined by the researcher based on tumor shrinkage). If the imaging achieves complete response (CR) or partial response (PR), suitable patients will undergo surgical treatment. Patients who are not suitable for surgery or have stable disease (SD)/progressive disease (PD) will receive concurrent chemoradiotherapy or concurrent chemoradiotherapy combined with PD-1 treatment (up to a total of 17 cycles). Arm2 group: Patients with stage III and IVA (T3NxM0, T4aNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 cycles. Patients who undergo surgery within 2 weeks will receive PD-1 monotherapy maintenance treatment or low-dose radiotherapy followed by PD-1 monotherapy maintenance treatment based on pathological results. Patients who do not achieve pathological complete response (pCR) and have positive surgical margins or extracapsular extension will receive concurrent chemoradiotherapy followed by PD-1 maintenance treatment (up to a total of 17 cycles). Patients without high-risk factors will receive PD-1 maintenance treatment after radiotherapy (up to a total of 17 cycles). After completion of treatment, all patients will be followed up every 3 months for 1 year. Subsequently, patients will be followed up every 6 months for 3 years. Thereafter, patients will be followed up annually. Patient recurrence and survival data will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage IVB cohort | Experimental | patients must undergo evaluation after receiving 2 cycles of PD-1 (pembrolizumab, 200mg, IV, Q3W) combined with platinum-based (cisplatin: 75 mg/m2, IV, Q3W) and albumin paclitaxel (260mg/m2, IV, Q3W) treatment (Arm 1 may receive a third cycle of treatment based on tumor regression). if achieving CR/PR on imaging, suitable for surgical treatment, not suitable for surgery or SD/PD patients, subsequent synchronous chemoradiotherapy or synchronous chemoradiotherapy combined with PD-1 (pembrolizumab) treatment (total of no more than 17 cycles). |
|
| Stage III-IVA cohort | Experimental | patients with stage III and IVA (T3NxM0, T4aNxM0) receive PD-1 (pembrolizumab, 200mg, IV, Q3W) combined with platinum-based chemotherapy (cisplatin: 75 mg/m2, IV, Q3W) and albumin-bound paclitaxel (260mg/m2, IV, Q3W) for 2 cycles. Patients who undergo surgery within 2 weeks based on pathological results are given PD-1 monotherapy maintenance treatment or low-dose radiotherapy followed by PD-1 monotherapy maintenance treatment if they achieve pathological complete response (pCR). Non-pCR patients with positive surgical margins or extracapsular extension after surgery receive PD-1 maintenance treatment after concurrent chemoradiotherapy (up to a maximum of 17 cycles). Patients without high-risk factors receive PD-1 maintenance treatment after radiotherapy (up to a maximum of 17 cycles). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Mainly used for neoadjuvant treatment and subsequent adjuvant or maintenance treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The proportion of subjects with best overall response (BOR) assessed as complete response (CR) or partial response (PR) according to RECIST 1.1 criteria. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Defined as the time from randomization to the date of first disease progression or death due to any cause, whichever occurs first. | 3 years |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohong Chen, Doctor | Contact | +86 13911071002 | trchxh@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 10000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 18, 2023 | Oct 18, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2023 | Oct 18, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | Mainly used for neoadjuvant treatment and concurrent chemoradiotherapy |
|
| Paclitaxel-albumin | Drug | Mainly used for neoadjuvant treatment |
|
|
According to RECIST v1.1 criteria, it assesses the proportion of subjects with complete response (CR), partial response (PR), and stable disease (SD) in terms of overall best response (BOR).
| 6 month |
| Time to objective response (TTR) | Defined as the duration from the start of medication to the date of first documented CR or PR (whichever occurs first). Tumor response is based on confirmed tumor response, and the response date is from the first observation, not the confirmed response. | 3 years |
| Duration of Response (DOR) | The duration from the date of first assessment as CR or PR to the date of first assessment as disease progression or death for subjects who achieved complete response or partial response (CR or PR). | 3 year |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |