Efficacy and Safety of DEB-BACE With Sequential Arotinib and Tirelizumab in the Treatment of Advanced NSCLC

NCT05380271 | Unknown Phase 2

• 1 other identifier: IAT-NSCLC-2022-04
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Non-Small Cell Lung

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

  up to 3 years

Secondary Outcomes (2)

• ORR

  up to 3 years

• Overall survival (OS)

  up to 3 years

Study Arms (2)

sequential DEB-BACE and Arotinib and Tirelizumab

EXPERIMENTAL

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).

Drug: sequential DEB-BACE and Arotinib and Tirelizumab

DEB-BACE alone

ACTIVE COMPARATOR

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.

Drug: DEB-BACE alone

Interventions

sequential DEB-BACE and Arotinib and Tirelizumab DRUG

DEB-BACE+Arotinib + Tirelizumab

sequential DEB-BACE and Arotinib and Tirelizumab

DEB-BACE alone DRUG

DEB-BACE alone

DEB-BACE alone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of clinically significant hepatic disease (ALT and/or AST \>5 times the upper normal limit);
• Women who are pregnant or lactating;
• Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
• Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.

Sponsors & Collaborators

• Gang Wu: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Gang Wu, M.D.

CONTACT

+86 13938570175; wuganghenan2015@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 18, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share