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

NCT03129256 | Completed Phase 2

• 1 other identifier: CCH001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer; Apatinib; S1

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival(PFS)

  PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

  2 years

Secondary Outcomes (4)

• Overall Survival(OS)

  2 years

• Objective response rate(ORR)

  2 years

• Disease Control Rate(DCR)

  2 years

• Adverse Events(AEs)

  2 years

Study Arms (1)

Apatinib & S-1

EXPERIMENTAL

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.

Drug: Apatinib Mesylate tablet combined with S-1 capsules

Interventions

Apatinib Mesylate tablet combined with S-1 capsules DRUG

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

Also known as: Ai Tan combined with S-1, Apatinib combined with S-1

Apatinib & S-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changzhou Cancer Hospital of Soochow University: lead

Study Sites (1)

Changzhou Cancer Hospital of Soochow University

Changzhou, Jiangsu, 213000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tong Zhou, Dr.

  Changzhou Cancer Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 26, 2017
• Study Start: December 1, 2016
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)