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Recruiting Phase 2 NCT04857164

Study of Pembrolizumab Combined with Chemotherapy in the First Line Therapy for R/M HNSCC in China

Trial Parameters

Condition Head and Neck Squamous Cell Carcinoma
Sponsor Yuankai Shi
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-04-30
Completion 2023-08-20
Interventions
Pembrolizumab combined with Chemotherapy

Brief Summary

This trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma

Eligibility Criteria

Inclusion Criteria: 1. Voluntarily sign written informed consent before screening; 2. Age 18\~75 years old; 3. ECOG physical status score 0-1 points; 4. Head squamous cell carcinoma (HNSCC) diagnosed by histology or cytology, the primary site is oral cavity, oral cavity Throat, lower throat or throat; 5. Recurrent and/or metastatic HNSCC without indications for local radical treatment; 6. According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there is at least one measurable lesion, right For lesions that have received radiotherapy in the past, only if there is clear disease progression 3 months after the end of radiotherapy, can it be Was selected as the target lesion; 7. There are a large number of tumor tissue samples for PD-L1 immunohistochemical detection; 8. The expected survival period exceeds 3 months; 9. The main organs function normally, that is, they meet the following standards: I. Blood routine (not receiving blood transfusion 14 months

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