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Not yet recruitingNCT05218759Updated Feb 1, 2022

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

An interventional study of Anlotinib in Non-Small Cell Lung Cancer, sponsored by Shanghai Chest Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-01.

Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Anlotinib
  • Non-Small Cell Lung Cancer
  • exosome
  • detection biomarker
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's planned enrollment of 30 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    arm A

    Progressive disease (PD) after anlotinib administration

    Drug: Anlotinib

  • Experimental
    arm B

    Stable disease (SD) after anlotinib administration

    Drug: Anlotinib

Interventions

  • DrugAnlotinib

    anlotinib administration at a dose of 10 mg daily

    Also known as: H20180004

06

What researchers measure

Primary outcomes

  1. PD

    Progressive disease (PD) after anlotinib administration

    Time frame: at the time of 2 months (2 cycles after treatment)

  2. SD

    Stable disease (SD) after anlotinib administration

    Time frame: at the time of 2 months (2 cycles after treatment)

Secondary outcomes

  1. Severe adverse reaction group

    Severe adverse reaction group after anlotinib administration

    Time frame: at the time of 2 months (2 cycles after treatment)

  2. Adverse reaction non-serious group

    Adverse reaction non-serious group after anlotinib administration

    Time frame: at the time of 2 months (2 cycles after treatment)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05218759
Lead sponsor
Shanghai Chest Hospital
Collaborators
3D Medicines
Responsible party
Aiqin Gu (Chief physician, Shanghai Chest Hospital) — Principal investigator
First posted
Feb 1, 2022
Start date
Feb 21, 2022 (estimated)
Primary completion
May 31, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Feb 1, 2022

Study contacts

Aiqin Gu, MD
Contact
Guaiqin11@126.com
+86-18017321300
Aiqin Gu, Chief physician
principal investigator · Shanghai Chest Hospital, Shanghai, China, 200030

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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