Exosomes Detection for the Prediction of the Efficacy and Adverse Reactions of Anlotinib in Patients With Advanced NSCLC

NCT ID: NCT05218759

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2025-10-31

Brief Summary

Exosomes detection for the prediction of the efficacy and adverse reactions of Anlotinib in patients with advanced NSCLC

Detailed Description

Explore blood exosomal miRNA as a biomarker for predicting the efficacy or risk of serious adverse reactions in patients with advanced lung adenocarcinoma (or lung squamous cell carcinoma) after anlotinib treatment.

Conditions

Non-Small Cell Lung Cancer

Study Design

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

Study Groups

arm A

Progressive disease (PD) after anlotinib administration

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

anlotinib administration at a dose of 10 mg daily

arm B

Stable disease (SD) after anlotinib administration

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

anlotinib administration at a dose of 10 mg daily

Interventions

Anlotinib

anlotinib administration at a dose of 10 mg daily

Intervention Type: DRUG

Other Intervention Names

H20180004

Eligibility Criteria

Inclusion Criteria

1. Patients who have signed informed consent.

2. Male or female, age between 18-75 years old.

3. Patients with advanced lung adenocarcinoma who failed standard treatment.

4. Complete prognostic assessment information.

5. Efficacy evaluation: PR/SD/PD.

6. Anlotinib single drug administration.

7. ECOG PS score: 0-1.

8. Patient's expected survival time is greater than 12 weeks.

9. The functions of main organs meets the following criteria: 1) absolute neutrophil count (ANC) ≥1.5×10^9/L; 2) white blood cell count (WBC) ≥3.0×10^9/L; 3) platelet (PLT) ≥100×10^9/L; 4) hemoglobin (Hb) ≥90g/L; 5); creatinine clearance ≥50ml/min or serum creatinine (Cr) ≤1.5×upper limit of normal (ULN); 6)serum total bilirubin (TBIL) ≤1.5×ULN; 7) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; 8) left ventricular ejection fraction (LVEF) ≥ the lower limit of the normal (50%); 9) Serum Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; 10) ALT and AST ≤ 5ULN; 11) activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN.

10. Women of childbearing age should make sure their pregnancy test is negative within 2 weeks before the study, and keep using contraceptive methods during the study and within 24 weeks after the last administration of Anlotinib. For men, they must agree to use contraceptive methods during the study period and also 24 weeks after the last administration of Anlotinib.

Exclusion Criteria

1. Patients whose plasma is not qualified for the test (hemolysis, precipitation, etc.)

2. Patients who have used Anlotinib before.

3. Pathological diagnosis results do not meet the requirements for entry.

4. Patients never used TKIs.

5. Patients with hemoptysis, more than 50mL per day.

6. Patients with other kinds of malignancies within 5 years.

7. Patients who have taken systemic therapy (immunotherapy, cytotoxic therapy, or other targeted therapies) within 6 weeks before grouping.

8. Patients who have symptoms of diseases that affect the patient's medication.

9. Patients who have suffered non-relieving toxicity from previous treatment.

10. Patients who have habitus of hemorrhage; the history of ulcer or fracture and non healing wounds.

11. Patients who have suffered arterial/venous thrombosis within 24 weeks.

12. Patients who have been diagnosed with mental disorder.

13. Patients who have suffered other diseases that may affect the patient's life safety and the results of this experiment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3D Medicines

INDUSTRY

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aiqin Gu

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aiqin Gu, Chief physician

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital, Shanghai, China, 200030

Central Contacts

Aiqin Gu, MD

Role: CONTACT

Guaiqin11@126.com

+86-18017321300

Other Identifiers

KS(Y)21217

Identifier Type: -

Identifier Source: org_study_id