A Study of Apatinib Plus Tegafur Gimeracil Oteracil in Recurrent/Metastatic Head and Neck Cancers

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study ID
NCT03096184
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Mesylate Tablets — DRUG
    500 mg qd.p.o. every day for 21 days as a cycle
  • Tegafur Gimeracil Oteracil Potassium Capsules — DRUG
    50mg bid p.o. every day for 14 days as a cycle

Study Details

This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck. The primary purpose of this study is to evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck

Key Dates

Start date
Dec 23, 2016
Status verified
Oct 2018
Primary completion
Jul 31, 2018
Completion
May 1, 2019

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Group
    Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment

Primary Outcome Measure

Progression-free survival(PFS) [ Time Frame: 2 years ]

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