NCT02943252

The Clinical Study of Apatinib Plus S1 for Patients With Advanced Non-squamous Head and Neck Cancer

PhaseⅡSingle-center, Open-label, Exploratory Clinical Study of Apatinib in Combination With S1 for the Patients With Advanced Non-squamous Head and Neck Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.

Detailed description

There is no standard therapy for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer. Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, which has been approved for the treatment of patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Vascular endothelial growth factor is highly expressed in non-squamous head and neck cancer and its expression correlates with stage, tumour size, vascular invasion, recurrence and metastasis. S1 is a new kind of oral fluorouracil antineoplastic chemotherapy drugs. In vitro, apatinib has synergy effect with fluorouracil. In this study, the investigators try to evaluate the efficacy and safety of apatinib and S1 in advanced non-squamous head and neck cancer and to validate the correlative biomarkers.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Apatinib	apatinib 500 mg in tablet once daily
DRUG	S1	S-1 40-60mg bid, days 1-14 , every 3 weeks

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2021-10-01
• First posted: 2016-10-24
• Last updated: 2016-10-24

Locations

1 site across 1 country: China