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A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX07+HLX10+chemotherapy | Experimental |
| |
| Placebo+HLX10+chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX07 | Drug | 1500 mg, D1,Q3W |
| |
| HLX10 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria) | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC and INV according to the RECIST v1.1 criteria. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guanzhou | Guangdong | 510060 | China |
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| Drug |
300 mg, D1, up to 2 years,Q3W |
|
| placebo | Drug | 1500 mg, D1,Q3W |
|
| chemotherapy | Drug | gemcitabine 1000 mg/m2, D1,D8; cisplatin 80 mg/m2,D1;Q3W, up to 6 cycles |
|
| ID | Term |
|---|---|
| C000722210 | HLX07 |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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