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This is a prospective, open-label, multicenter, single-arm clinical study. A total of 30 patients with locally advanced nasopharyngeal carcinoma who have not received prior systemic treatment are planned to be enrolled at three centers. After enrollment, the patients will receive induction therapy with Iparomlimab/Tuvorlimab(QL-1706) in combination with a modified TPF regimen, followed by concurrent chemoradiotherapy with cisplatin according to the standards of clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen | Experimental | Patients will receive three cycles of Albumin-bound paclitaxel 260 mg/m² + cisplatin 75 mg/m² (divided on days 1 - 3) + S1 calculated according to body surface area, taken twice daily (days 1 - 14) + Iparomlimab/Tuvorlimab(QL-1706) 5 mg/kg (day 1). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen | Drug | Induction therapy: Albumin-bound paclitaxel 260 mg/m² + cisplatin 75 mg/m² (divided on days 1 - 3) + S1 calculated according to body surface area, taken twice daily (days 1 - 14) + Iparomlimab/Tuvorlimab(QL-1706) 5 mg/kg (day 1). One cycle lasts for 21 days, and the treatment continues for three consecutive cycles. Concurrent chemotherapy: Cisplatin 80 mg/m², divided on days 1 - 3. One cycle lasts for 21 days, and the treatment continues for two consecutive cycles. Radiotherapy regimen: Whole-course IMRT. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rates after induction therapy | Higher scores mean a better outcome. | From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days). |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Higher scores mean a better outcome. | From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days). |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
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Inclusion Criteria:
Age: ≥ 18 years old;
Patients with nasopharyngeal carcinoma diagnosed by pathology (including histology or cytology), with a clinical stage of III - IV (excluding T3N0 - 1) (according to the UICC/AJCC TNM staging system (8th edition));
No prior systematic treatment (surgery, radiotherapy, chemotherapy, etc.); At least one measurable lesion on imaging examination (according to RECIST criteria version 1.1);
ECOG PS: 0 - 1 points;
Expected survival time ≥ 3 months;
Normal function of major organs, meeting the following criteria:
Blood routine tests should meet the following (without blood transfusion within 14 days):
Biochemical tests should meet the following criteria:
Male subjects and women of childbearing potential must use contraception from the start of the first dose of the study drug until 24 weeks after the last dose of the study drug;
Normal function of major organs, with basically normal blood routine, blood biochemistry and coagulation function tests;
The investigator believes that the patient will benefit from the treatment in terms of survival;
The patient voluntarily participates in this study and provides a written informed consent form.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361003 | China |
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Higher scores mean a worse outcome.
| From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days). |
| PFS | Higher scores mean a better outcome. | From the time of enrollment until two years after the completion of the treatment. |
| OS | Higher scores mean a better outcome. | From the time of enrollment until two years after the completion of the treatment |