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Clinical study of first-line therapy with Apatinib Mesylate in combination with chemotherapy for EGFR-negative advanced non-small cell lung cancer

Clinical study of first-line therapy with Apatinib Mesylate in combination with chemotherapy for EGFR-negative advanced non-small cell lung cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-17013304
Enrollment
Unknown
Registered
2017-11-08
Start date
2017-11-07
Completion date
Unknown
Last updated
2017-11-13

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

Conditions

NSCLC

Interventions

A:Apatinib + Docetaxel + Platinum
B: Docetaxel + Platinum

Sponsors

2nd People's Hospital of Fuyang City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~75 years old, man or woman; 2. The pathological/cytology diagnosis of Primary advanced Non-small cell lung cancer patients,with measurable focus (the longest tumor diameter >=10mm, the smallest nodule >=15mm and the slice thickness =90 g/L; ANC>=1.5*10^9/L; PLT>=80*10^9/L; (2) 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,myocardial infarction, arrhythmia or Class II cardiac sufficiency; 3. 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; 4. 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; 5. Unresolved = CTCAE 2 toxicity caused by the original treatment; 6. Have a variety of factors that affect the taking and absorption of oral drugs ; such as can not swallow, chronic diarrhea and intestinal obstruction, significantly affect the taking and absorption of drugs, etc. 7. Investigator judgment that may affect the conduct of clinical studies and case studies determined.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactFengde Zhao

2nd People's Hospital of Fuyang City

1376481296@qq.com+86 13855875770

Outcome results

None listed

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