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This study aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy | Experimental | Penpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle. Adjuvant therapy was started within 6 weeks after surgery:Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab). Non-MPR patients receive standard adjuvant therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penpulimab injection | Drug | Penpulimab is a human immunoglobulin G1(IgG1) monoclonal antibody (mAb) directly programmed cell death-1 (PD-1). AK105 can effectively prevent human PD-1 binds to programmed cell death-1 ligand 1(PD-L1) and programmed cell death-1 ligand 2(PD-L2)ï¼› 200mg,D1, IV(21 days/cycle). |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response(MPR) | Major pathologic response is based on the pathological examination on the post-operative specimens. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-control Rate(DCR) | The proportion of subjects response of CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks). | Baseline up to 3 years. |
| Adverse event rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Ruan, PhD | Contact | 18019790370 | doctorruanmin@situ.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| cisplatin | Drug | Cisplatin :75mg/m2, D1, IV(21 days/cycle) |
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| albumin-paclitaxel | Drug | albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle) |
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The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
| Baseline up to 3 years. |
| Disease-free survival at 2 years(DFS at 2 years) | The proportion of subjects disease-free survival at 2 years | Baseline up to 2 years. |
| Overall Response Rate (ORR) | The proportion of subjects who achieves a best overall response of CR or PR. | Baseline up to 3 years. |
| Local recurrence-free survival at 2years(LRFS at 2 years) | The proportion of subjects local recurrence-free survival at 2years | Baseline up to 2 years. |
| distant metastasis-free survival at 2 years(DMFS at 2 years) | The proportion of subjects distant metastasis-free survival at 2years | Baseline up to 2 years. |
| OS at 2 years | The overall survival time refers to the time from initiating inductive therapy to death due to any cause. | Baseline up to 2 years. |
| pathologic complete response(pCR) | Pathological examination showed the presence of 0% active tumor in the tissue specimen | One year |
| 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 |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000720860 | penpulimab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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