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Clinical study for anlotinib monotherapy and anlotinib combined with vinorelbine in the second-line treatment of advanced lung squamous cell carcinoma

Clinical study for anlotinib monotherapy and anlotinib combined with vinorelbine in the second-line treatment of advanced lung squamous cell carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017614
Enrollment
Unknown
Registered
2018-08-06
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

Squamous Cell Lung Cancer

Interventions

one:anlotinib
two:Erlotinib + vinorelbine
three:vinorelbine

Sponsors

Anhui Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion 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 =90 g/L; ANC>=1.5*10^9/L; PLT>=80*10^9/L; (2) TBIL 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

Exclusion criteria: 1. pregnant or lactating; 2. Has violated the pulmonary artery or hollow type lung squamous carcinoma; 3. Patients who are concurrently treated with radiotherapy; 4. 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; 5. 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; 6. 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; 7. Accompanied by the central nervous system transfer; 8. 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; 9. Investigator judgment that may affect the conduct of clinical studies and case studies determined.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactQingming Shi

Anhui Chest Hospital

shqm0324@163.com+86 13063495524

Outcome results

None listed

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