Clinical study of Apatinib Mesylate Tablets in the Second-line treatment of Advanced Squamous Cell Lung Cancer

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OPC-16009048
• Date of registration: 2016-08-19
• Prospective Registration: Yes
• Primary sponsor: Anhui Chest Hospital
• Public title: Clinical study of Apatinib Mesylate Tablets in the Second-line treatment of Advanced Squamous Cell Lung Cancer
• Scientific title: Clinical study of Apatinib Mesylate Tablets in the Second-line treatment of Advanced Squamous Cell Lung Cancer
• Date of first enrolment: 2016-08-22
• Target sample size: none:30;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=15292
• Study type: Observational study
• Study design: Case series
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Qingming Shi
• Affiliation: Anhui Chest Hospital

• Name: Qingming Shi
• Affiliation: Anhui Chest Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18~80 years old, man or woman;
2. The pathological/cytology diagnosis of advanced squamous cell lung cancer patients,with measurable focus (the longest tumor diameter >=10mm, the smallest nodule >=15mm and the slice thickness <=5mm using the CT scan);
3. The patients have received at least one platinum-based chemotherapy;
4. ECOG score 0-2;
5. The expected survival more than three months;
6. The main organ function, that meet the following criteria:
(1) HB>=90 g/L; ANC>=1.5*10^9/L; PLT>=80*10^9/L;
(2) TBIL <1.5ULN; ALT and AST <2.5ULN, and for patients with liver metastases is <5ULN;
(3) serum Cr<=1.5ULN or endogenous creatinine clearance rate within> 45 ml/min (Cockcroft-Gault formula);
7. women of childbearing age must have taken reliable contraceptive measures or 7 days before the group performed a pregnancy test (serum or urine), and the result is negative, and willing to experiment and during the last eight weeks after administration of the test drugs using appropriate methods contraception. For men shall be agreed to during the trial and after the last administration of the test drugs eight weeks using appropriate methods of contraception or sterilization surgery;
8. The subjects voluntarily joined the study, and informed consent, good compliance, with the follow-up.
Exclusion criteria: 1. pregnant or lactating;2.Has violated the pulmonary artery or hollow type lung squamous carcinoma;3.After suffering from high blood pressure and antihypertensive medications can not fall within the normal range (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) above the level of suffering I myocardial ischemia,myocardial infarction, arrhythmia or Class II cardiac sufficiency; 4.coagulation abnormalities (INR> 1.5 or APTT>1.5ULN + 4 seconds, or APTT>1.5 ULN), having bleeding tendency,or treated with thrombolysis and anticoagulation;5.Patients with clear gastrointestinal bleeding concerns(including the following situations: local active ulcerative lesions, and defecate occult blood (++)); A period of 6 months prior to the start of the study gastrointestinal bleeding event has occurred;6.Accompanied by the central nervous system transfer;7.A period of 4 weeks prior to the start of taking the study drug, =CTCAE 2 pneumorrhagia or =CTCAE 3 other organs bleeding event has occurred;8.Investigator judgment that may affect the conduct of clinical studies and case studies determined.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

Squamous Cell Lung Cancer

Intervention(s)

none:combined S-1;

Primary Outcome(s)

PFS;

Source(s) of Monetary Support

self-financing