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This is a study to evaluate the efficacy and safety of TQB2450 injection combination with Intensity-modulated Radiotherapy in patients with inoperable locally recurrent nasopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2450+Intensity modulated radiotherapy | Experimental | TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-dayï¼›The total dose of radiotherapy should meet PTVnx: 60Gy/27Fr/2.22Gy, PTVnd: 60-64Gy/27Fr/2.22-2.37Gy, PTV1: 54Gy/27Fr/2.00Gy, once a day, 5 times/week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2450 | Drug | TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Percentage of participants achieving complete response (CR) and partial response (PR). | up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate(DCR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 48 weeks |
| Duration of Response (DOR) | The time when the participants first achieved complete or partial remission to disease progression. |
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Inclusion Criteria:
Exclusion Criteria:
1. Operable patients with local recurrence, including rT2 (the tumor is confined to the surface of the parapharyngeal space, and the distance from the internal carotid artery > 0.5 cm) and rT3 (the tumor is confined to the bottom wall of the sphenoid sinus, and the distance from the internal carotid artery and cavernous sinus > 0.5 cm) ; 2.Combined diseases and medical history:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Hospital | Guangzhou | Guangdong | 510030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41067232 | Derived | Xia TL, Huang W, Liu YP, Feng ZK, Chen SY, Ding X, Peng L, Wu WB, Yu D, Yang AQ, Li X, Tang Y, He X, Hua YJ, You R, Chen MY. TQB2450 plus intensity-modulated radiotherapy in recurrent nasopharyngeal carcinoma: An open-label, single-arm, phase II trial. Med. 2025 Nov 14;6(11):100846. doi: 10.1016/j.medj.2025.100846. Epub 2025 Oct 8. |
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|
| Intensity modulated radiotherapy | Radiation | Intensity-modulated conformal radiotherapy (IMRT) is a kind of three dimensional conformal radiotherapy, which requires the dose intensity in the radiation field to be adjusted according to certain requirements. |
|
| up to 48 weeks |
| Progression-free survival (PFS) | PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause. | up to 48 weeks |
| 12-month progression-free survival rate | 12-month PFS defined as the time from first administration until the first documented progressive disease (PD) or death from any cause within 12 months. | up to 48 weeks |
| 12-month survival rate | 12-month survival rate defined as the time from first administration to death from any cause within 12 months. | up to 48 weeks |
| 24-month survival rate | 24-month survival rate defined as the time from first administration to death from any cause within 24 months. | up to 96 weeks |
| Local regional recurrence-free survival (LRRFs) | The time interval between the patient's first medication and the appearance of local imaging progress. | up to 48 weeks |
| Distant metastasis-free survival (DMFS) | The time interval between the patient's first medication and the appearance of distant metastasis imaging progression or death. | up to 48 weeks |
| Overall survival (OS) | OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. | up to 96 weeks |
| 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 |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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