Clincosm LogoSign in Get a demo

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

Sponsor
Gang Wu (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05380271
Collaborator
(none)
60
Enrollment
2
Arms
41
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: sequential DEB-BACE and Arotinib and Tirelizumab
  • Drug: DEB-BACE alone
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: sequential DEB-BACE and Arotinib and Tirelizumab

First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 ~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 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. 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+Arotinib + Tirelizumab
Active Comparator: DEB-BACE alone

First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 ~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 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
DEB-BACE alone

Outcome Measures

Primary Outcome Measures

  1. PFS [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 Outcome Measures

  1. ORR [up to 3 years]

    ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria

  2. Overall survival (OS) [up to 3 years]

    The time from recruitment to death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;

  2. Aged >=18 years, <= 85 years;

  3. Patients with NSCLC diagnosed by imaging and histopathology; TNM stage was III-IV;

  4. Initial diagnosis, failure of first-line treatment, refusal or inability to perform routine treatment (surgery, radiotherapy and chemotherapy);

  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;

  6. Expected survival period ≥ 3 months.

Exclusion Criteria:

  1. Known hypersensitivity to any of the study drugs or excipients;

  2. Hypertension that is not controlled by the drug;

  3. International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;

  4. WBC count < 3000 /mm3;

  5. Platlet count < 50000 /mm3;

  6. Poorly controlled diabetes before enrollment;

  7. Clinically significant electrolyte abnormalities judged by researchers;

  8. Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment;

  9. 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%;

  10. Active infection or serious infection that is not controlled by drug;

  11. History of clinically significant hepatic disease (ALT and/or AST >5 times the upper normal limit);

  12. Women who are pregnant or lactating;

  13. Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;

  14. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gang Wu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gang Wu, Chief physician, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier:
NCT05380271
Other Study ID Numbers:
  • IAT-NSCLC-2022-04
First Posted:
May 18, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of May 18, 2022