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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05218759
• Other study ID #: KS(Y)21217
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: January 2022
• Source: Shanghai Chest Hospital
• Contact: Aiqin Gu, MD
• Phone: +86-18017321300
• Email: Guaiqin11[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Anlotinib
anlotinib administration at a dose of 10 mg daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	3D Medicines

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD	Progressive disease (PD) after anlotinib administration	at the time of 2 months (2 cycles after treatment)
Primary	SD	Stable disease (SD) after anlotinib administration	at the time of 2 months (2 cycles after treatment)
Secondary	Severe adverse reaction group	Severe adverse reaction group after anlotinib administration	at the time of 2 months (2 cycles after treatment)
Secondary	Adverse reaction non-serious group	Adverse reaction non-serious group after anlotinib administration	at the time of 2 months (2 cycles after treatment)