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A prospectiv, single-arm study of Apatinib unite docetaxel in the treatment of advanced squamous cell carcinoma of the lung

A prospectiv, single-arm study of Apatinib unite docetaxel in the treatment of advanced squamous cell carcinoma of the lung

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-15007443
Enrollment
Unknown
Registered
2015-11-23
Start date
2015-11-24
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced squamous cell carcinoma of the lung

Interventions

none:Apatinib unite docetaxel

Sponsors

the second people's hospital of lianyungang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. The pathological diagnosis of lung squamous cell carcinoma patients with advanced refractory, with measurable disease, and the distance between the great vessels> 5mm; 3. The patients received at least one platinum-based chemotherapy combined with the failure of the standard; 4. ECOG score: 0-2; 5. The expected survival more than three months; 6. Subjects received treatment caused other damage has been restored, which accepts nitroso or mitomycin interval >=6 weeks; acceptance of other cytotoxic drugs, radiation or surgery >=4 weeks, and the wound had completely healed; 7. The main organ function, that meet the following criteria: (1) subject to the standard blood test (14 days not blood transfusion and blood products, not using G-CSF and other hematopoietic stimulating factor corrected): 1) HB>=90 g/L; 2) ANC>=1.5*10^9/L; 3) PLT>=80*10^9/L; (2) biochemical tests must meet the following criteria: 1) TBIL 45 ml/min (Cockcroft-Gault formula); 8. 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; 9. The subjects voluntarily joined the study, and informed consent, good compliance, with the follow-up.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating ; 2. 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 or myocardial infarction, arrhythmia (including QT interval of >=440 ms) and Class II heart failure; 3. obvious factors of oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 4. coagulation abnormalities (INR> 1.5 or prothrombin time (PT)> ULN + 4 seconds, or APTT>1.5 ULN), having bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 5. Before the first 4 weeks of treatment appears >=CTCAE 2 stage pulmonary hemorrhage; occur before the first 4 weeks of treatment in other parts >=CTCAE 3 level hemorrhage; 6. The first dose Action / venous thromboembolic events occurred within the first six months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 7. The use of anticoagulants or patients with vitamin K antagonists such as warfarin, heparin therapy or an analogue thereof; in prothrombin time international normalized ratio (INR) <=1.5 premise, to permit the use of low-dose prophylactic purposes Hua warfarin (1mg orally, once daily) or low-dose aspirin (80mg daily dose between the 100mg); 8. investigator judgment that may affect the conduct of clinical studies and case studies determined; With active brain metastases.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactJiang Hua
lygrenxuan@hotmail.com+86 13505130679

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026