Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Tegafur

Protein Kinase Inhibitors

Enzyme Inhibitors

Antimetabolites

Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment

500 mg qd.p.o. every day for 21 days as a cycle

Apatinib Mesylate Tablets

50mg bid p.o. every day for 14 days as a cycle

Tegafur Gimeracil Oteracil Potassium Capsules

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

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

A Non-randomized Phase II Study of Apatinib Mesylate Tablets Plus Tegafur Gimeracil Oteracil Potassium Capsules in Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

from date of enrollment until date of first death from any cause, assessed up to 2 years

Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

M.D.

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Fuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)\< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 \< BSA （body surface area）\< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA（body surface area） \>1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w;

Fuquinitinib+Tegafur Gimeracil Oteracil

Yang xiaobing, PhD

Li xiaoyan

This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC

Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer

An Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC

PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator

OS is the time from enrollment to death due to any cause.

overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Apatinib Plus Tegafur Gimeracil Oteracil in Recurrent/Metastatic Head and Neck Cancers	NCT03096184	Head and Neck S...	Apatinib Mesyla... Tegafur Gimerac...	18 Years - 70 Years	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer	NCT06255379	Metastasis Colo... Colon Cancer Rectal Cancer	Fuquinitinib+Te...	18 Years - 75 Years	Guangzhou University of Traditional Chinese Medicine
Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer	NCT06255379	Metastasis Colo... Colon Cancer Rectal Cancer	Fuquinitinib+Te...	18 Years - 75 Years	Guangzhou University of Traditional Chinese Medicine

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