A Study of Apatinib and Tegafur Gimeracil Oteracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study ID
NCT03267121
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 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
    25mg/㎡ 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 induction chemotherapy in locally advanced squamous cell carcinoma of head and neck patients who were judged surgically unresectable or appropriate for non-surgical definitive therapy.The primary purpose of this study is to evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in locally advanced squamous cell carcinoma of head and neck

Key Dates

Start date
Oct 1, 2017
Status verified
Jul 2022
Primary completion
Sep 30, 2020
Completion
Nov 1, 2020

Study Design

Enrollment
38 participants (actual)
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

Objective Response Rate (CR+PR) [ Time Frame: 9 weeks ]

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