Trial intelligence / Profile preview

Apatinib and S-1 Induction in LA-HNSCC

NCT03267121Phase 2

Key facts

Status
Completed
Start
Oct 2017
Primary completion
Sep 2020
Countries
1
Sponsor
Shanghai Ninth People's Hospital
Modality
Small Molecules
Conditions
head and neck squamous cell carcinoma (HNSCC)
01

Overview

Phase 2, open-label, single-arm trial of Rivoceranib in head and neck squamous cell carcinoma (HNSCC), sponsored by Shanghai Ninth People's Hospital. Primary endpoint: Objective Response Rate at 9 weeks. Started Oct 2017; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Study Group

    Apatinib + Tegafur gimeracil oteracil induction chemotherapy

03

Who it enrols

Patients with histologically confirmed locally advanced SCCHN who are surgically unresectable or refuse surgery, with ECOG 0-1 and adequate organ function.

04

Endpoints

Primary

  • Objective Response Rate

Secondary

  • Number of Participants With at Least One Grade 3-4 Toxicity

  • Progression Free Survival

  • Overall Survival

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