MedDataX Logo

An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer

NCT ID: NCT03129256

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is to explore the potential efficacy and safety of low-dose Apatinib combined with S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with oral apatinib and S-1 after treatment failure of standard regimen.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). The anti-angiogenesis effect of apatinib has been proved in preclinical tests. Phase II study has showed an improvement of progression free survival in pretreated patients. S-1, an oral fluoropyrimidine has considerable effectiveness with mild side effect in patients failed to standard treatments. The purpose of this study is to evaluate the potential efficacy and safety of low-dose Apatinib combined with S-1 in heavily pretreated patients with advanced lung cancer. And to explore the biomarkers of antiangiogenesis therapy and the possible mechanisms of treatment resistance on the basis of next generation sequencing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small Cell Lung Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

non-small cell lung cancer Apatinib S1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Apatinib & S-1

Apatinib Mesylate tablet combined with S-1 Capsules Apatinib Mesylate tablet 250mg once daily combined with S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules) 40mg\~60mg twice daily by mouth, d1-14, repeated every 3 weeks.

Group Type EXPERIMENTAL

Apatinib Mesylate tablet combined with S-1 capsules

Intervention Type DRUG

Oral use with low-dose Apatinib combined with S-1 until disease progression

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apatinib Mesylate tablet combined with S-1 capsules

Oral use with low-dose Apatinib combined with S-1 until disease progression

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ai Tan combined with S-1 Apatinib combined with S-1

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pathologically confirmed Non-small cell lung cancer
* Patients with extracranial measurable lesions
* Patients with NSCLC failed for standard treatments
* Eastern Cooperative Oncology Group performance status score: 0\~2 and life expectancy of more than 3 months
* Major organs functioning properly
* Compliance is good and agreed to cooperate with the survival of follow-up
* Informed consent

Exclusion Criteria

* Contraindications for investigational agents
* Patients with clinical symptoms of brain metastases or meningeal metastasis
* Tumor invade big vessels or close to big vessels
* Uncontrolled hypertension
* Abnormal coagulation (INR\>1.5 or Prothrombin Time\>ULN+4, or Activated Partial Thromboplastin Time\>1.5 ULN), bleeding tendency or receiving coagulation therapy
* Hemoptysis, more than 2.5ml daily
* Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
* Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
* Received big surgery, had bone fracture or ulcer in 4 weeks.
* Urine protein≥++, or urine protein in 24 hours≥1.0g
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Changzhou Cancer Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tong Zhou, Dr.

Role: PRINCIPAL_INVESTIGATOR

Changzhou Cancer Hospital of Soochow University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changzhou Cancer Hospital of Soochow University

Changzhou, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCH001

Identifier Type: -

Identifier Source: org_study_id