Multicenter randomized controlled clinical study of Nedaplatin&Gemcitabine comparing with Cisplatin & Gemcitabine for first-line therapy of Advanced lung squamous cell carcinoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13004124

Enrollment

Unknown

Registered

2013-05-30

Start date

2012-09-01

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

Advanced lung squamous cell carcinoma

Interventions

1:application of Palonosetron Hydrochloride

2:application of Palonosetron Hydrochloride

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of stage IV non-small cell lung squamous cell carcinomas by Cytopathology,Histology; 2. By definition of RECIST1.1,there should be measurable lesions; 3. Aged from 18~70; 4. Physical condition: KPS=70 or graded ECOG should be 0~1, expected lifetime=3months; 5. For patients: 1) Liver function: serum bilirubin = 1.5ULN,Serum transaminases = 2ULN; If hepatic metastases happened, serum bilirubin = 2ULN, Serum transaminases = 5ULN; 2) Renal function: Serum creatinine should be less than the upper limit of normal, or caculated Creatinine clearance = 60ml/min; 3) Bone marrow reserve: White blood cell (WBC) = 4.0x10^9/L, Absolute neutrophil count (ANC) =2.0x10^9/L, Platelets =100x10^9/L, Hemoglobin =100g/L; 6. There should be no serious history of drug allergy; 7. There should be no history of malignancy, excluding cured cervical carcinoma in situ, basal skin cancer; 8. Had not received previous anticancer treatment, or received only for non-metastatic tumors adjuvant or neoadjuvant chemotherapy, but up to beginning of the study the treatment should be over 6 months or more; 9. Should comply with written informed consent of ICH-GCP guidelines.

Exclusion criteria

Exclusion criteria: 1) Symptomatic patients with brain metastases and symptomatic patients with bone marrow metastasis, Cognitive impairment; 2) There are other serious complications; 3) Pregnant women and nursing mothers, women who did not take contraceptive measures of childbearing age; 4) Allergic patients to this medicine or dextran; 5) Participated in other drugs' experiments within 4 weeks; 6) Observasion sites for curative effect combined radiotherapy; 7) Other cases that researchers believe that patients should not take part in this experiment.

Design outcomes

Primary

Measure	Time frame
PFS;	—

Secondary

Measure	Time frame
DCR;OS;QOL;	—

Countries

China

Contacts

Public ContactHuang Cheng

Fujian Provincial Tumor Hospital

simceremg@126.com+86 13905010379

Outcome results

None listed

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