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Neoadjuvant chemotherapy of bevacizumab, gemcitabine and cisplatin in stage IIIA non-small cell lung cancer: control and multi-center study

Neoadjuvant chemotherapy of bevacizumab, gemcitabine and cisplatin in stage IIIA NSCLC

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-12002397
Enrollment
Unknown
Registered
2012-06-04
Start date
2012-06-01
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

Non-small cell lung cancer

Interventions

1:Chemotherapy combined with AVASTIN
2:Chemotherapy

Sponsors

The first affiliated hospital of Guangzhou MC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases; 2. 18 years or older; 3. ECOG Performance Status no more than 2; 4. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI; 5. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5*10^9/L, platelets 100*10^9/L; 6. Total bilirubin 1.5*upper limit of normal (ULN); 7. ALT and AST < 2.5*ULN in the absence of liver metastases, or < 5*ULN in case of liver metastases; 8. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).

Exclusion criteria

Exclusion criteria: 1. Tumor invasion or surrounding the large blood vessels showed by the imaging; 2. Using the full amount drug for inhibition of platelet function now or recently (pre-treatment 10 days), anticoagulants or thrombolytic agent treatment, allowing preventive anticoagulants; 3. Non-healing wounds, active peptic ulcer or fracture; 4. Abdominal fistula, gastrointestinal perforation or intra-abdominal abscess 6 months before first treatment; 5. Be allergic to bevacizumab, gemcitabine or cisplatin; 6. Major surgey or serious trauma 2 months before first treatment; 7. Mixed non-adenocarcinoma cell lung cancer histology.

Design outcomes

Primary

MeasureTime frame
Tumor ORR;

Secondary

MeasureTime frame
PFS;The rate of pathology down-stage of lymph nodes;pathology CR;The rate of complete rescetion of tumor;Safety;Quality of life;

Countries

China

Contacts

Public ContactJianxing He
hejx@vip.163.com+86 020 83062825

Outcome results

None listed

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