Efficacy and Safety of Bronchial Arterial Infusion Chemotherapy Combined With Drug Loaded Microspheres Embolization With Sequential Arotinib and Tirelizumab in the Treatment of Advanced NSCLC
Overview
- Phase
- Phase 2
- Intervention
- sequential DEB-BACE and Arotinib and Tirelizumab
- Conditions
- Carcinoma, Non-Small Cell Lung
- Sponsor
- Gang Wu
- Enrollment
- 60
- Primary Endpoint
- PFS
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a prospective, open-labelled study to evaluate the efficacy and safety of arterial infusion chemotherapy combined with drug loaded microspheres embolization with sequential arotinib and tirelizumab in the treatment of advanced NSCLC. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
Investigators
Gang Wu
Chief physician
The First Affiliated Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
- •Aged \>=18 years, \<= 85 years;
- •Patients with NSCLC diagnosed by imaging and histopathology; TNM stage was III-IV;
- •Initial diagnosis, failure of first-line treatment, refusal or inability to perform routine treatment (surgery, radiotherapy and chemotherapy);
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Expected survival period ≥ 3 months.
Exclusion Criteria
- •Known hypersensitivity to any of the study drugs or excipients;
- •Hypertension that is not controlled by the drug;
- •International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN;
- •WBC count \< 3000 /mm3;
- •Platlet count \< 50000 /mm3;
- •Poorly controlled diabetes before enrollment;
- •Clinically significant electrolyte abnormalities judged by researchers;
- •Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment;
- •Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade \> 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) \< 50%;
- •Active infection or serious infection that is not controlled by drug;
Arms & Interventions
sequential DEB-BACE and Arotinib and Tirelizumab
1. First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 \~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 2. Second treatment. After infusion chemotherapy, Callispheres microspheres is used for embolization: Callispheres microspheres (300-500 μ m) 1tube was loaded and adsorbed THP (40 \~ 600mg/m2) End point of embolization: stagnation of blood flow in tumor feeding artery. 3. The third treatment. Arotinib, 8-12mg, oral (stop oral for 1W every 3W).Tirelizumab, 200mg, intravenous drip (every 3W).
Intervention: sequential DEB-BACE and Arotinib and Tirelizumab
DEB-BACE alone
1. First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 \~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 2. Second treatment. After infusion chemotherapy, Callispheres microspheres is used for embolization: Callispheres microspheres (300-500 μ m) 1tube was loaded and adsorbed THP (40 \~ 600mg/m2) End point of embolization: stagnation of blood flow in tumor feeding artery.
Intervention: DEB-BACE alone
Outcomes
Primary Outcomes
PFS
Time Frame: up to 3 years
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Secondary Outcomes
- ORR(up to 3 years)
- Overall survival (OS)(up to 3 years)