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The study is being conducted to evaluate the safety and efficacy of tislelizumab combined with GX regimen versus tislelizumab combined with GP regimen in the first-line treatment of nasopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab combined with GX | Experimental | Patients will receive tislelizumab combined with GX regimen: Tislelizumab:200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine:1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles. Capecitabine: 1000mg/m2, bid,po, d1-14, q3; treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. |
|
| Tislelizumab combined with GP | Experimental | Patients will receive tislelizumab combined with GX regimen: Tislelizumab: 200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine: 1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles; Cisplatin: 80mg/m2, ivgtt, d1 (high-dose cisplatin antiemetic and hydration regimen), q3w,repeat 4 ~ 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab combined with GX | Drug | Tislelizumab:200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine:1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles. Capecitabine: 1000mg/m2, bid,po, d1-14, q3; treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the progression-free survival of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECIST v1.1. | Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free. | up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the objective response rate of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECISTv1.1. | Complete remission rate+ partial remission rate | up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the duration of response of R/M NPC patients treated with tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the intention-to-treat (ITT) analysis set evaluated by the researchers according to RECISTv1.1. | Time from the date of first partial remission or complete remission to the date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongmei Ji, M.D | Contact | 021-64175590 | 83650 | jidongmei2000@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongmei Ji, M.D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| Tislelizumab combined with GP | Drug | Tislelizumab: 200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine: 1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles; Cisplatin: 80mg/m2, ivgtt, d1 (high-dose cisplatin antiemetic and hydration regimen), q3w,repeat 4 ~ 6 cycles. |
|
| up to approximately 3 years |
| To compare the overall survival (OS) of R/M NPC patients treated with tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the intention-to-treat (ITT) analysis set evaluated by the researchers according to RECISTv1.1. | Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive. | up to approximately 3 years |
| To compare the safety and tolerance of R/M NPC patients treated with tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the intention-to-treat (ITT) analysis set evaluated by the researchers according to RECISTv1.1. | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to approximately 3 years |
| 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 |