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Temporal bone cancer accounts for 0.2% of head and neck cancers. Advanced temporal bone cancer often involves structures such as apices, internal carotid artery canals, and dura mater, and negative margins cannot be obtained during surgery. The recurrence rate after surgery is as high as 70%, and the 2-year survival rate is only 11%. Crestor, or paprolizumab, is a monoclonal antibody to PD1 that blocks the interaction between PD1 and the dura mater. The NCCN guidelines recommend that paprolizumab be used in combination with platinum-based anti-tumor agents. The NCCN guidelines recommend pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent, unresectable head and neck squamous carcinoma, but this regimen is not recommended for the treatment of recurrent, unresectable head and neck squamous carcinoma. This study is intended to investigate the use of pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent unresectable squamous head and neck cancer. This study investigates the effectiveness of pablizumab in combination with cisplatin and 5-FU for the adjuvant treatment of recurrent, unresectable temporal bone cancer. temporal bone cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paprizumab combined with cisplatin and 5-FU | Experimental | Patients received four cycles of paprizumab (200mg iv, 21-day cycle) in combination with 5-fu (500mg/m2 iv) plus cisplatin (80mg/m2 iv, 21-day cycle). Reassessment after completion of neoadjuvant chemotherapy was performed in operable patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paprizumab combined with cisplatin and 5-FU | Drug | Patients with advanced temporal bone cancer were treated with pabulizumab combined with cisplatin and 5-FU |
|
| Measure | Description | Time Frame |
|---|---|---|
| The resectability rate of pablizumab in combination with cisplatin and 5-FU for unresectable temporal bone squamous carcinoma as neoadjuvant therapy | Resectability rate of tumors | up to three months |
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Inclusion Criteria:
Patients with advanced temporal bone carcinoma evaluated by an otolaryngologist as non-R0 resectable; CPS score > 20.
Patients who had undergone surgery, chemotherapy, radiotherapy, etc.
Patients with T4 advanced temporal bone cancer, Patients with nasopharyngeal carcinoma after radiotherapy
Hematology, biochemistry, and organ function:
General admission criteria:
Exclusion Criteria:
Patients who had cancer other than temporal bone cancer during the five years before the initiation of treatment in this study were excluded from: fully cured with surgery and disease-free survival of at least 5 years; carcinoma in situ of the cervix; cured basal cell carcinoma; bladder epithelial neoplasms (including Ta and Tis);
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suijun CHEN, doctor | Contact | 13609757219 | Chensuijun1974@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Suijun CHEN, doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510030 | China |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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