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An exploratory study on the safety and efficacy of Paclitaxel for injee in (Albumin Bound) combined with Nedaplatin arterial perfusion in the treatment of stage IIIb non-small cell lung cancer

An exploratory study on the safety and efficacy of Paclitaxel for injee in (Albumin Bound) combined with Nedaplatin arterial perfusion in the treatment of stage IIIb non-small cell lung cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035359
Enrollment
Unknown
Registered
2020-08-09
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-10

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

Conditions

Stage IIIb non-small cell lung cancer

Interventions

case series:Albumin paclitaxel 200mg/m2 + nedaplatin 70mg/m2, bronchial artery perfusion, d1, q3w

Sponsors

People's Hospital of Jianyang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with non-small cell lung cancer confirmed by pathology (histology or cytology) (according to WHO classification in 2015); 2. According to the eighth edition of TNM staging, the subjects were patients with stage IIIB non-small cell lung cancer without surgical indications; 3. Patients with measurable tumor focus (spiral CT scan >=10 mm, meeting RECIST 1.1 standard); 4. Patients who had not received systemic chemotherapy before and were unwilling to receive systemic chemotherapy or could not tolerate concurrent chemoradiotherapy for various reasons; 5. Subjects whose functions of important organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of the study and treatment) Absolute neutrophil count (ANC) >=1.5x10^9/L; Platelet >=100x10^9/L; Hemoglobin >=9g/dl; Serum albumin >=2.8g/dl; Bilirubin =50 ml/min; Myocardial enzymes Thyroid function was normal. 6. Aged 18 to 75 years old, both male and female; 7. ECoG PS: subjects with 0-1 score; 8. Subjects without contraindications of vascular intervention; 9. Patients with an expected survival time of more than 3 months; 10. Male / female subjects with reproductive potential must agree to receive contraceptive guidance during the study, at least 120 days after the end of treatment; 11. Patients who the researchers believe can benefit from it; 12. The patients were informed and followed up (12) and signed the ICF.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Those who do not conform to the pathological diagnosis of NSCLC; 3. Patients with abnormal coagulation function (INR > 2.0, Pt > 16S) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy are allowed to use low-dose aspirin and low molecular weight heparin prophylactically; 4. The absolute neutrophil count (ANC) was lower than 1500 / mm3; 5. The subjects had severe allergy to paclitaxel or human albumin; 6. The subjects had platinum intolerance; 7. The subjects had serious heart, lung, kidney and liver diseases; 8. Pregnant or lactating women; 9. The patients whose expected survival time was less than 3 months; 10. Subjects who had significant clinical bleeding symptoms or had definite bleeding tendency within 3 months before enrollment; 11. Other patients who were not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Adverse Event;Serious Adverse Event;

Secondary

MeasureTime frame
Objective Response Rate;progression-free survival;Disease Control Rate;quality of life;Overall survival;

Countries

China

Contacts

Public ContactWeng Liping

People's Hospital of Jianyang

591332366@qq.com+86 18784338619

Outcome results

None listed

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