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

NCT ID: NCT05380271

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

sequential DEB-BACE and Arotinib and Tirelizumab

Intervention Type: DRUG

DEB-BACE+Arotinib + 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.

Group Type: ACTIVE_COMPARATOR

DEB-BACE alone

Intervention Type: DRUG

DEB-BACE alone

Interventions

sequential DEB-BACE and Arotinib and Tirelizumab

DEB-BACE+Arotinib + Tirelizumab

Intervention Type: DRUG

DEB-BACE alone

DEB-BACE alone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gang Wu

OTHER

Sponsor Role: lead

Responsible Party

Gang Wu

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Gang Wu, M.D.

Role: CONTACT

wuganghenan2015@163.com

+86 13938570175

Other Identifiers

IAT-NSCLC-2022-04

Identifier Type: -

Identifier Source: org_study_id