NCT04146402

SCT-I10A Plus Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma

SCT-I10A Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase III, Multicenter, Randomized, Double-blinded Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma

Detailed description

This is a Phase III, multicenter, randomized, double-blinded trial designed to evaluate Overall survival (OS) of SCT-I10A combined with standard chemotherapy in patients living with Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	SCT-I10A+chemo	SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle Standard chemotherapy: Cisplatin+5-FU
DRUG	Placebos+chemo	Placebo, 200 mg intravenous (IV) on Day 1 of each 3-week cycle Standard chemotherapy: Cisplatin+5-FU

Timeline

• Start date: 2019-12-31
• Primary completion: 2022-01-29
• Completion: 2022-07-30
• First posted: 2019-10-31
• Last updated: 2020-02-05

Locations

1 site across 1 country: China