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

NCT05218759 | Unknown

• 1 other identifier: KS(Y)21217
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Non-Small Cell Lung Cancer

Keywords

Anlotinib; Non-Small Cell Lung Cancer; exosome; detection biomarker

Outcome Measures

Primary Outcomes (2)

• PD

  Progressive disease (PD) after anlotinib administration

  at the time of 2 months (2 cycles after treatment)

• SD

  Stable disease (SD) after anlotinib administration

  at the time of 2 months (2 cycles after treatment)

Secondary Outcomes (2)

• Severe adverse reaction group

  at the time of 2 months (2 cycles after treatment)

• Adverse reaction non-serious group

  at the time of 2 months (2 cycles after treatment)

Study Arms (2)

arm A

EXPERIMENTAL

Progressive disease (PD) after anlotinib administration

Drug: Anlotinib

arm B

EXPERIMENTAL

Stable disease (SD) after anlotinib administration

Drug: Anlotinib

Interventions

Anlotinib DRUG

anlotinib administration at a dose of 10 mg daily

Also known as: H20180004

arm A; arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have signed informed consent.
• Male or female, age between 18-75 years old.
• Patients with advanced lung adenocarcinoma who failed standard treatment.
• Complete prognostic assessment information.
• Efficacy evaluation: PR/SD/PD.
• Anlotinib single drug administration.
• ECOG PS score: 0-1.
• Patient's expected survival time is greater than 12 weeks.
• 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.
• 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.

You may not qualify if:

• Patients whose plasma is not qualified for the test (hemolysis, precipitation, etc.)
• Patients who have used Anlotinib before.
• Pathological diagnosis results do not meet the requirements for entry.
• Patients never used TKIs.
• Patients with hemoptysis, more than 50mL per day.
• Patients with other kinds of malignancies within 5 years.
• Patients who have taken systemic therapy (immunotherapy, cytotoxic therapy, or other targeted therapies) within 6 weeks before grouping.
• Patients who have symptoms of diseases that affect the patient's medication.
• Patients who have suffered non-relieving toxicity from previous treatment.
• Patients who have habitus of hemorrhage; the history of ulcer or fracture and non healing wounds.
• Patients who have suffered arterial/venous thrombosis within 24 weeks.
• Patients who have been diagnosed with mental disorder.
• Patients who have suffered other diseases that may affect the patient's life safety and the results of this experiment.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• 3D Medicines: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Aiqin Gu, Chief physician

  Shanghai Chest Hospital, Shanghai, China, 200030

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiqin Gu, MD

CONTACT

+86-18017321300; Guaiqin11@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: February 21, 2022
• Primary Completion: May 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share