NCT03744208

SCT200 Injection in Patients With Head and Neck Squamous Cell Carcinoma

A Study of Evaluating Recombinant Human Anti-EGFR Monoclonal Antibody (SCT200) and Standard Chemotherapy for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shi Yuankai · Unknown
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of first-line with recombinant anti-EGFR monoclonal antibody（SCT200）and standard chemotherapy in patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

Detailed description

This open label, single-arm and multicenter phase II study is designed to evaluate Objective Response Rate (ORR) of first-line with anti-EGFR monoclonal antibody（SCT200）and standard chemotherapy in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Anti-EGFR monoclonal antibody	DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression

Timeline

• Start date: 2018-12-30
• Primary completion: 2019-12-31
• Completion: 2020-05-28
• First posted: 2018-11-16
• Last updated: 2018-11-16