Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study in to observe the effectiveness and safety of paclitaxel (albumin-bound type) combined with cisplatin, PD-1 inhibitor and IMRT in the treatment of locally advanced nasopharyngeal carcinoma.
This trial is a prospective, open, single-arm phase II clinical trial. The trial will enroll 40 patients with nasopharyngeal cancer stage III-IVA (UICC 8th edition). Subjects will receive paclitaxel (albumin-bound) combined with cisplatin and PD-1 inhibitor (sintilimab) neoadjuvant therapy and radical concurrent chemotherapy and radiotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel(Album-bound) | Experimental | Subjects will receive neoadjuvant therapy with paclitaxel (albumin-bound) combined with cisplatin and PD-1 inhibitor (sintilimab) as well as radical concurrent radiotherapy and chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel(Albumin-bound) | Combination Product | Three courses of albumin-bound paclitaxel combined with cisplatin and PD-1 monoclonal antibody neoadjuvant treatment followed by cisplatin combined with IMRT (intensity modulated conformal radiotherapy) concurrent radiotherapy and chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | According to European Solid Tumor Efficacy Evaluation Standard (RECIST) | 1 month after the end of all treatments |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013660 | Taxes |
| D002945 | Cisplatin |
| D000082082 | Immune Checkpoint Inhibitors |
| C000632826 | sintilimab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D013812 | Therapeutics |
Not provided
Not provided